The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, And Acetabular Shells With Mesh Ingrowth Surface With Peri-a.
| Device ID | K982248 |
| 510k Number | K982248 |
| Device Name: | HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-26 |
| Decision Date | 1998-08-31 |
| Summary: | summary |