The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Dall-miles Cable Grip (a-grip).
| Device ID | K984432 |
| 510k Number | K984432 |
| Device Name: | DALL-MILES CABLE GRIP (A-GRIP) |
| Classification | Cerclage, Fixation |
| Applicant | HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Frank Maas |
| Correspondent | Frank Maas HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-14 |
| Decision Date | 1999-02-24 |
| Summary: | summary |