The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Titanium Alloy Songer Cable System.
| Device ID | K920201 |
| 510k Number | K920201 |
| Device Name: | TITANIUM ALLOY SONGER CABLE SYSTEM |
| Classification | Cerclage, Fixation |
| 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-15 |
| Decision Date | 1992-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978048048 | K920201 | 000 |
| 00673978048024 | K920201 | 000 |