Choicespine, LP
Chesterland, OH, US
Choicespine, LP appears in FDA device records in Chesterland, OH. FDA records list 26 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Choicespine, LP between 2008 and 2019. The busiest year on record is 2017, with 6. The most recent is 2019, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 2 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 6 |
| 2018 | 3 |
| 2019 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190227 | Boomerang™ Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K183397 | ChoiceSpine Stealth Cervical Spacer System | ODP | Substantially Equivalent | |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | MQP | Substantially Equivalent | |
| K182721 | Choice Spine Navigation System | OLO | Substantially Equivalent | |
| K183214 | Raven Lumbar Plate System | KWQ | Substantially Equivalent | |
| K180519 | HARRIER-SA™ Lumbar Interbody System | OVD | Substantially Equivalent | |
| K172816 | TiGer Shark™ System | MAX | Substantially Equivalent | |
| K173215 | Choice Spine Laminoplasty™ Fixation System | NQW | Substantially Equivalent | |
| K171489 | Acapella Cervical Spacer System | OVE | Substantially Equivalent | |
| K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | MQP | Substantially Equivalent | |
| K171456 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | NKB | Substantially Equivalent | |
| K170821 | ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System | NKB | Substantially Equivalent | |
| K170942 | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | NKB | Substantially Equivalent | |
| K170953 | Tomcat Cervical Spinal System | OVE | Substantially Equivalent | |
| K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) | MAX | Substantially Equivalent | |
| K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | NKB | Substantially Equivalent | |
| K153107 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System | MAX | Substantially Equivalent | |
| K152515 | TOMCAT Cervical Spinal System | OVE | Substantially Equivalent | |
| K132049 | THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS | NKB | Substantially Equivalent | |
| K140142 | CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) | MAX | Substantially Equivalent | |
| K133214 | BLACKBIRD SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K121850 | Typhoon(TM) Facet Screw Fixation System | MRW | Substantially Equivalent | |
| K120570 | CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM | MQP | Substantially Equivalent | |
| K102204 | CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K091926 | CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM | KWQ | Substantially Equivalent | |
| K073669 | ORIA NATURA SPACER | MAX | 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
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- OLOOrthopedic Stereotaxic Instrument
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- MQPSpinal Vertebral Body Replacement Device
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain