The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Meniscal Repair Device.
| Device ID | K974538 |
| 510k Number | K974538 |
| Device Name: | MENISCAL REPAIR DEVICE |
| 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 | 1997-12-03 |
| Decision Date | 1998-03-03 |
| Summary: | summary |