The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Duration Stabilized Uhmwpe Acetabular Components.
| Device ID | K972792 |
| 510k Number | K972792 |
| Device Name: | DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Frank Maas |
| Correspondent | Frank Maas HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1997-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327032284 | K972792 | 000 |
| 07613327032109 | K972792 | 000 |
| 07613327032093 | K972792 | 000 |
| 07613327032086 | K972792 | 000 |
| 07613327032079 | K972792 | 000 |
| 07613327032062 | K972792 | 000 |
| 07613327032055 | K972792 | 000 |
| 07613327032048 | K972792 | 000 |
| 07613327032031 | K972792 | 000 |
| 07613327032024 | K972792 | 000 |
| 07613327032017 | K972792 | 000 |
| 07613327032000 | K972792 | 000 |
| 07613327031997 | K972792 | 000 |
| 07613327031980 | K972792 | 000 |
| 07613327031973 | K972792 | 000 |
| 07613327032116 | K972792 | 000 |
| 07613327032123 | K972792 | 000 |
| 07613327032130 | K972792 | 000 |
| 07613327032277 | K972792 | 000 |
| 07613327032260 | K972792 | 000 |
| 07613327032253 | K972792 | 000 |
| 07613327032246 | K972792 | 000 |
| 07613327032239 | K972792 | 000 |
| 07613327032222 | K972792 | 000 |
| 07613327032215 | K972792 | 000 |
| 07613327032208 | K972792 | 000 |
| 07613327032192 | K972792 | 000 |
| 07613327032185 | K972792 | 000 |
| 07613327032178 | K972792 | 000 |
| 07613327032161 | K972792 | 000 |
| 07613327032154 | K972792 | 000 |
| 07613327032147 | K972792 | 000 |
| 07613327031966 | K972792 | 000 |