The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Preloaded Soft Tissue Anchor.
| Device ID | K963932 |
| 510k Number | K963932 |
| Device Name: | PRELOADED SOFT TISSUE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-01 |
| Decision Date | 1997-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854019792 | K963932 | 000 |
| 20845854019785 | K963932 | 000 |
| 10845854015070 | K963932 | 000 |
| 10845854014905 | K963932 | 000 |