The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Cerclage Wire Crimp Sleeve.
| Device ID | K931246 |
| 510k Number | K931246 |
| Device Name: | CERCLAGE WIRE CRIMP SLEEVE |
| Classification | Cerclage, Fixation |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-11 |
| Decision Date | 1994-02-22 |