The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Tsrh(tm) Lateral Offset Plate.
| Device ID | K914306 |
| 510k Number | K914306 |
| Device Name: | TSRH(TM) LATERAL OFFSET PLATE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-25 |
| Decision Date | 1992-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978039688 | K914306 | 000 |