The following data is part of a premarket notification filed by Applied Osteo Systems, Inc. with the FDA for Interference Screw.
| Device ID | K943160 |
| 510k Number | K943160 |
| Device Name: | INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | APPLIED OSTEO SYSTEMS, INC. 1243 ALPINE RD. SUITE 221 Walnut Creek, CA 94596 -4370 |
| Contact | Scott Huntley |
| Correspondent | Scott Huntley APPLIED OSTEO SYSTEMS, INC. 1243 ALPINE RD. SUITE 221 Walnut Creek, CA 94596 -4370 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 1994-07-01 |
| Decision Date | 1994-09-30 |