The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Endofix Absorbable Interference Screw.
| Device ID | K954246 |
| 510k Number | K954246 |
| Device Name: | ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Tedd Gosian |
| Correspondent | Tedd Gosian ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| 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 | 1995-09-11 |
| Decision Date | 1996-02-15 |