The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Acetabular Shell W/screw Holes.
| Device ID | K933102 |
| 510k Number | K933102 |
| Device Name: | HOWMEDICA ACETABULAR SHELL W/SCREW HOLES |
| 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 | 1993-06-24 |
| Decision Date | 1994-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327036312 | K933102 | 000 |
| 07613327036190 | K933102 | 000 |
| 07613327036206 | K933102 | 000 |
| 07613327036213 | K933102 | 000 |
| 07613327036220 | K933102 | 000 |
| 07613327036237 | K933102 | 000 |
| 07613327036244 | K933102 | 000 |
| 07613327036251 | K933102 | 000 |
| 07613327036268 | K933102 | 000 |
| 07613327036275 | K933102 | 000 |
| 07613327036282 | K933102 | 000 |
| 07613327036299 | K933102 | 000 |
| 07613327036305 | K933102 | 000 |
| 07613327036183 | K933102 | 000 |