The following data is part of a premarket notification filed by Vertera, Inc. with the FDA for Hedgehog Cervical Interbody Fusion Device.
| Device ID | K143685 |
| 510k Number | K143685 |
| Device Name: | Hedgehog Cervical Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Vertera, Inc. 311 Ferst Drive NW, Suite L1328 Atlanta, GA 30332 |
| Contact | Stephen Laffoon |
| Correspondent | Stephen Laffoon Vertera, Inc. 311 Ferst Drive NW, Suite L1328 Atlanta, GA 30332 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B14220000132160 | K143685 | 000 |
| B1422000001009080 | K143685 | 000 |
| B1422000001008080 | K143685 | 000 |
| B1422000000914080 | K143685 | 000 |
| B1422000000914000 | K143685 | 000 |
| B1422000000912080 | K143685 | 000 |
| B1422000000912000 | K143685 | 000 |
| B1422000000911080 | K143685 | 000 |
| B1422000000911000 | K143685 | 000 |
| B1422000000910080 | K143685 | 000 |
| B1422000000910000 | K143685 | 000 |
| B1422000000909080 | K143685 | 000 |
| B1422000000909000 | K143685 | 000 |
| B1422000000908080 | K143685 | 000 |
| B1422000001010080 | K143685 | 000 |
| B1422000001011080 | K143685 | 000 |
| B1422000001012080 | K143685 | 000 |
| B14220000132140 | K143685 | 000 |
| B14220000132120 | K143685 | 000 |
| B14220000132110 | K143685 | 000 |
| B14220000132100 | K143685 | 000 |
| B14220000132090 | K143685 | 000 |
| B14220000132080 | K143685 | 000 |
| B14220000128140 | K143685 | 000 |
| B14220000128120 | K143685 | 000 |
| B14220000128110 | K143685 | 000 |
| B14220000128100 | K143685 | 000 |
| B14220000128090 | K143685 | 000 |
| B14220000128080 | K143685 | 000 |
| B1422000001014080 | K143685 | 000 |
| B1422000000908000 | K143685 | 000 |