The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Precision Hip System Proximal Femoral Spacer #6259.
| Device ID | K860442 |
| 510k Number | K860442 |
| Device Name: | PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-04 |
| Decision Date | 1986-05-06 |