The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Dall-miles Homogenous Vitallium Cable.
| Device ID | K961283 |
| 510k Number | K961283 |
| Device Name: | DALL-MILES HOMOGENOUS VITALLIUM CABLE |
| Classification | Cerclage, Fixation |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Frank Maas |
| Correspondent | Frank Maas HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-03 |
| Decision Date | 1996-05-22 |
| Summary: | summary |