The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Meridian St Femoral Stem And Vitalock Solid Back Shell W/ Peri-apatite Coating.
| Device ID | K971206 |
| 510k Number | K971206 |
| Device Name: | MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret Crowe |
| Correspondent | Margaret Crowe HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-12 |
| Decision Date | 1998-02-11 |
| Summary: | summary |