The following data is part of a premarket notification filed by Cufex Microsurgical, Inc. with the FDA for Acufex Cannulated Bone Tunnel Plugs.
| Device ID | K925437 |
| 510k Number | K925437 |
| Device Name: | ACUFEX CANNULATED BONE TUNNEL PLUGS |
| Classification | Arthroscope |
| Applicant | CUFEX MICROSURGICAL, INC. 130FORBES BLVD. Mansfield, MA 02048 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson CUFEX MICROSURGICAL, INC. 130FORBES BLVD. Mansfield, MA 02048 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-28 |
| Decision Date | 1992-12-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 23596010495918 | K925437 | 000 |
| 00885554012293 | K925437 | 000 |
| 00885554010725 | K925437 | 000 |