The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Reconstruction Plate System.
| Device ID | K924085 |
| 510k Number | K924085 |
| Device Name: | RECONSTRUCTION PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Contact | Bailey Lipscomb |
| Correspondent | Bailey Lipscomb SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-13 |
| Decision Date | 1992-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902815522 | K924085 | 000 |
| 00885074525884 | K924085 | 000 |