The following data is part of a premarket notification filed by Acu-med, Inc. with the FDA for Osteo-clage(tm) Cerciage Cable System.
| Device ID | K921480 |
| 510k Number | K921480 |
| Device Name: | OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | ACU-MED, INC. 10950 SW 5TH, SUITE 170 Beaveton, OR 97005 |
| Contact | Randy Huebner |
| Correspondent | Randy Huebner ACU-MED, INC. 10950 SW 5TH, SUITE 170 Beaveton, 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 | 1992-03-30 |
| Decision Date | 1992-06-26 |