The following data is part of a premarket notification filed by Choice Spine, Lp with the FDA for Choice Spine Lumbar Spacer System (sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (harrier™), Choice Spine Vertebral Body Replacement System (hawkeye™).
| Device ID | K162103 |
| 510k Number | K162103 |
| Device Name: | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CHOICE SPINE, LP 400 Erin Drive Knoxville, TN 37919 |
| Contact | Kim Finch |
| Correspondent | Kim Finch CHOICE SPINE, LP 400 Erin Drive Knoxville, TN 37919 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-29 |
| Decision Date | 2016-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996170666 | K162103 | 000 |
| 00840996157315 | K162103 | 000 |
| 00840996163712 | K162103 | 000 |
| 00840996163729 | K162103 | 000 |
| 00840996163736 | K162103 | 000 |
| 00840996163743 | K162103 | 000 |
| 00840996163750 | K162103 | 000 |
| 00840996163767 | K162103 | 000 |
| 00840996163774 | K162103 | 000 |
| 00840996163781 | K162103 | 000 |
| 00840996163798 | K162103 | 000 |
| 00840996163804 | K162103 | 000 |
| 00840996170628 | K162103 | 000 |
| 00840996170635 | K162103 | 000 |
| 00840996170642 | K162103 | 000 |
| 00840996170659 | K162103 | 000 |
| 00840996157308 | K162103 | 000 |