The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Interference Screw.
| Device ID | K960962 |
| 510k Number | K960962 |
| Device Name: | INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854015190 | K960962 | 000 |
| 20845854014919 | K960962 | 000 |
| 20845854014308 | K960962 | 000 |
| 20845854013837 | K960962 | 000 |
| 20845854013509 | K960962 | 000 |
| 20845854015220 | K960962 | 000 |