The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for R.r.p.s. Radius Reconstrution Plating System.
| Device ID | K961496 |
| 510k Number | K961496 |
| Device Name: | R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Frank Maas |
| Correspondent | Frank Maas HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-18 |
| Decision Date | 1996-06-28 |
| Summary: | summary |