The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Linvatec Stasys-pes Fixation Device.
| Device ID | K934321 |
| 510k Number | K934321 |
| Device Name: | LINVATEC STASYS-PES FIXATION DEVICE |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Martha C Miller |
| Correspondent | Martha C Miller 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 | 1993-09-03 |
| Decision Date | 1995-05-10 |