Custom Spine, Inc.
Conway, NH, US
Custom Spine, Inc. appears in FDA device records in Conway, NH. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Custom Spine, Inc. between 2005 and 2015. The busiest year on record is 2009, with 3. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K143143 | PATHWAY ELIF | MAX | Substantially Equivalent | |
| K132596 | PROPOSED OPTIMUS | OVD | Substantially Equivalent | |
| K120597 | KOMPREDA | MRW | Substantially Equivalent | |
| K111726 | PATHWAY AVID | MAX | Substantially Equivalent | |
| K111774 | PATHWAY MODEL 07XXXX | MAX | Substantially Equivalent | |
| K111099 | ISSYS LP SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K101151 | REGENT ANTERIOR CERVICAL PLATE | KWQ | Substantially Equivalent | |
| K092904 | PATHWAY IVB/VBR | ODP | Substantially Equivalent | |
| K091134 | CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE | KWQ | Substantially Equivalent | |
| K090566 | PATHWAY AVID | MAX | Substantially Equivalent | |
| K080281 | PATHWAY | MAX | Substantially Equivalent | |
| K072866 | ISSYS LP SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K070281 | ISSYS LP SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K043522 | ISSYS PEDICLE SCREW SYSTEM | KWP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1819-2013 | Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation. | On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain