Blackstone Medical, Inc.
Springfield, MA, US
Blackstone Medical, Inc. appears in FDA device records in Springfield, MA. FDA records list 45 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 11 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 45 510(k) clearances for Blackstone Medical, Inc. between 1997 and 2010. The busiest year on record is 2002, with 9. The most recent is 2010, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 9 |
| 2003 | 8 |
| 2004 | 6 |
| 2005 | 4 |
| 2006 | 2 |
| 2008 | 9 |
| 2009 | 1 |
| 2010 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093926 | FIREBIRD SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K100614 | HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES | KWQ | Substantially Equivalent | |
| K092624 | FIREBIRD SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K082797 | BLACKSTONE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K081684 | BLACKSTONE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K082235 | BLACKSTONE PILLAR XL PEEK SPACERS | MAX | Substantially Equivalent | |
| K081849 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE | OVD | Substantially Equivalent | |
| K081177 | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM | MAX | Substantially Equivalent | |
| K080407 | BLACKSTONE SFS PARALLEL ROD CONNECTORS | MNI | Substantially Equivalent | |
| K080394 | BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM | KWP | Substantially Equivalent | |
| K073420 | BLACKSTONE ASCENT MULTIAXIAL SCREWS | KWP | Substantially Equivalent | |
| K073654 | BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR | KWP | Substantially Equivalent | |
| K061229 | UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM | KWQ | Substantially Equivalent | |
| K060350 | CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM | MQP | Substantially Equivalent | |
| K051246 | CONSTRUX MINI PEEK VBR SYSTEM | MQP | Substantially Equivalent | |
| K043548 | BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM | KWQ | Substantially Equivalent | |
| K050892 | HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K043338 | BLAKSTONE LAMINOPLASTY FIXATION SYSTEM | NQW | Substantially Equivalent | |
| K042514 | MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | |
| K042100 | BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR | MNI | Substantially Equivalent | |
| K041939 | BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS | MQP | Substantially Equivalent | |
| K033702 | BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM | MQP | Substantially Equivalent | |
| K033980 | BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) | KWP | Substantially Equivalent | |
| K040034 | BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER | MNI | Substantially Equivalent | |
| K032700 | BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS | MQP | Substantially Equivalent | |
| K030744 | BLACKSTONE SURGICAL TITANIUM MESH | MQP | Substantially Equivalent | |
| K030581 | BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) | MNH | Substantially Equivalent | |
| K030197 | BLACKSTONE POSTERIOR CERVICAL SYSTEM | KWP | Substantially Equivalent | |
| K030595 | BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM | KWQ | Substantially Equivalent | |
| K030862 | BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR | MNI | Substantially Equivalent | |
| K022965 | BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE | KWQ | Substantially Equivalent | |
| K030241 | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K023498 | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K022605 | BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER | KWQ | Substantially Equivalent | |
| K022399 | BLACKSTONE SPINAL FIXATION SYSTEM SPACER | KWQ | Substantially Equivalent | |
| K020620 | BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) | KWQ | Substantially Equivalent | |
| K020600 | BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) | KWQ | Substantially Equivalent | |
| K020674 | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW | MNH | Substantially Equivalent | |
| K013885 | BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS | MNI | Substantially Equivalent | |
| K012184 | BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM | KWQ | Substantially Equivalent | |
| K013558 | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW | KWQ | Substantially Equivalent | |
| K003735 | BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR | MNI | Substantially Equivalent | |
| K994217 | BLACKSTONE SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K974885 | BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K972768 | BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM | HRX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- MQPSpinal Vertebral Body Replacement Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1615-2010 | 8.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread. | Terminated | ||
| Z-1614-2010 | 7.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread. | Terminated | ||
| Z-1613-2010 | 6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread. | Terminated | ||
| Z-1612-2010 | 5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread. | Terminated | ||
| Z-1611-2010 | 4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread. | Terminated | ||
| Z-1653-2010 | Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile. | The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured. | Terminated | ||
| Z-1144-2010 | Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. Intended to promote fusion of the cervical spine and occipitothoracic junction. | The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium. | Terminated | ||
| Z-1655-2009 | Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants. | Product marketed without an approved 510(k) | Terminated | ||
| Z-0363-2008 | Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104. | Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a comprom | Terminated | ||
| Z-0478-2008 | Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA 01104 (The Hallmark Anterior Cervical Plate Systems consists of an assortment of implantable titanium alloy plates and bone screws that are provided non-sterile) | Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification | Terminated | ||
| Z-0716-06 | ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092 | Pedicle Screw may disengage in post op period requiring intervention | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain