The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Interference Screw And Screwdriver.
| Device ID | K883910 |
| 510k Number | K883910 |
| Device Name: | ACUFEX INTERFERENCE SCREW AND SCREWDRIVER |
| Classification | Screw, Fixation, Bone |
| Applicant | ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Contact | Richard E Franko |
| Correspondent | Richard E Franko ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-15 |
| Decision Date | 1988-10-12 |