The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arthrotek Interference Screw.
| Device ID | K982497 |
| 510k Number | K982497 |
| Device Name: | ARTHROTEK INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary Verstynen |
| Correspondent | Mary Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-20 |
| Decision Date | 1998-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304009936 | K982497 | 000 |
| 00880304008526 | K982497 | 000 |
| 00880304007192 | K982497 | 000 |
| 00880304006669 | K982497 | 000 |
| 00880304004047 | K982497 | 000 |
| 00880304004030 | K982497 | 000 |
| 00880304003262 | K982497 | 000 |