The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arthrotek Set Screw.
| Device ID | K932721 |
| 510k Number | K932721 |
| Device Name: | ARTHROTEK SET SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-04 |
| Decision Date | 1994-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304011168 | K932721 | 000 |
| 00880304002586 | K932721 | 000 |