The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Sentry Anterior Spinal System.
| Device ID | K930807 |
| 510k Number | K930807 |
| Device Name: | SENTRY ANTERIOR SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-16 |
| Decision Date | 1993-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978045184 | K930807 | 000 |
| 00673978041186 | K930807 | 000 |
| 00673978041193 | K930807 | 000 |
| 00673978041209 | K930807 | 000 |
| 00673978041216 | K930807 | 000 |
| 00673978041223 | K930807 | 000 |
| 00673978041230 | K930807 | 000 |
| 00673978041247 | K930807 | 000 |
| 00673978044897 | K930807 | 000 |
| 00673978044903 | K930807 | 000 |
| 00673978044910 | K930807 | 000 |
| 00673978045160 | K930807 | 000 |
| 00673978045177 | K930807 | 000 |
| 00673978041179 | K930807 | 000 |