The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Antegra-t.
| Device ID | K081568 |
| 510k Number | K081568 |
| Device Name: | ANTEGRA-T |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Kirsten Stowell |
| Correspondent | Kirsten Stowell SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-04 |
| Decision Date | 2008-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98104103053S0 | K081568 | 000 |
| H98104102039S0 | K081568 | 000 |
| H98104102041S0 | K081568 | 000 |
| H98104102043S0 | K081568 | 000 |
| H98104102045S0 | K081568 | 000 |
| H98104102047S0 | K081568 | 000 |
| H98104102049S0 | K081568 | 000 |
| H98104102051S0 | K081568 | 000 |
| H98104102053S0 | K081568 | 000 |
| H98104103037S0 | K081568 | 000 |
| H98104103039S0 | K081568 | 000 |
| H98104103041S0 | K081568 | 000 |
| H98104103043S0 | K081568 | 000 |
| H98104103045S0 | K081568 | 000 |
| H98104103047S0 | K081568 | 000 |
| H98104103049S0 | K081568 | 000 |
| H98104103051S0 | K081568 | 000 |
| H98104102037S0 | K081568 | 000 |