The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bioscrew Absorbable Interference Screw.
| Device ID | K960940 |
| 510k Number | K960940 |
| Device Name: | BIOSCREW ABSORBABLE INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman, Ph.d. |
| Correspondent | Carol A Weideman, Ph.d. LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | HWC |
| Subsequent Product Code | MAI |
| Subsequent Product Code | MNU |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-08 |
| Decision Date | 1996-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854014476 | K960940 | 000 |
| 20845854013561 | K960940 | 000 |
| 20845854013592 | K960940 | 000 |
| 20845854013684 | K960940 | 000 |
| 20845854013721 | K960940 | 000 |
| 20845854013738 | K960940 | 000 |
| 20845854013745 | K960940 | 000 |
| 20845854013752 | K960940 | 000 |
| 20845854014001 | K960940 | 000 |
| 20845854014049 | K960940 | 000 |
| 20845854014131 | K960940 | 000 |
| 20845854014339 | K960940 | 000 |
| 20845854014360 | K960940 | 000 |
| 20845854014391 | K960940 | 000 |
| 20845854014407 | K960940 | 000 |
| 20845854014445 | K960940 | 000 |
| 20845854014452 | K960940 | 000 |
| 20845854013479 | K960940 | 000 |