The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arthrotek Interference Screw.
| Device ID | K934469 |
| 510k Number | K934469 |
| Device Name: | ARTHROTEK INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn 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 | 1993-09-10 |
| Decision Date | 1994-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304412231 | K934469 | 000 |
| 00880304117310 | K934469 | 000 |
| 00880304117303 | K934469 | 000 |
| 00880304011175 | K934469 | 000 |
| 00880304009028 | K934469 | 000 |
| 00880304008465 | K934469 | 000 |
| 00880304008458 | K934469 | 000 |
| 00880304008311 | K934469 | 000 |
| 00880304008304 | K934469 | 000 |
| 00880304005532 | K934469 | 000 |
| 00880304002791 | K934469 | 000 |
| 00880304002685 | K934469 | 000 |
| 00880304002593 | K934469 | 000 |
| 00880304002579 | K934469 | 000 |
| 00880304002562 | K934469 | 000 |
| 00880304117358 | K934469 | 000 |
| 00880304411937 | K934469 | 000 |
| 00880304412200 | K934469 | 000 |
| 00880304412194 | K934469 | 000 |
| 00880304412163 | K934469 | 000 |
| 00880304412149 | K934469 | 000 |
| 00880304412132 | K934469 | 000 |
| 00880304412125 | K934469 | 000 |
| 00880304412118 | K934469 | 000 |
| 00880304412101 | K934469 | 000 |
| 00880304412071 | K934469 | 000 |
| 00880304412040 | K934469 | 000 |
| 00880304412033 | K934469 | 000 |
| 00880304412026 | K934469 | 000 |
| 00880304412002 | K934469 | 000 |
| 00880304411999 | K934469 | 000 |
| 00880304002555 | K934469 | 000 |