The following data is part of a premarket notification filed by Biomet Manufactuting Corp. with the FDA for G7 Finned Acetabular Shell.
| Device ID | K142746 |
| 510k Number | K142746 |
| Device Name: | G7 Finned Acetabular Shell |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET MANUFACTUTING CORP. 56 EAST BELL DRIVE P.O.BOX 587 Warsaw, IN 46581 |
| Contact | Tracy Johnson |
| Correspondent | Dean Heit BIOMET UK LTD. WATERTON INDUSTRIAL ESTATE Bridgend, GB Cf31 3xa |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| Subsequent Product Code | PBI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-24 |
| Decision Date | 2014-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304672185 | K142746 | 000 |
| 00880304672079 | K142746 | 000 |
| 00880304672062 | K142746 | 000 |
| 00880304672055 | K142746 | 000 |
| 00880304672246 | K142746 | 000 |
| 00880304672239 | K142746 | 000 |
| 00880304672222 | K142746 | 000 |
| 00880304672215 | K142746 | 000 |
| 00880304672208 | K142746 | 000 |
| 00880304672086 | K142746 | 000 |
| 00880304672093 | K142746 | 000 |
| 00880304672178 | K142746 | 000 |
| 00880304672161 | K142746 | 000 |
| 00880304672154 | K142746 | 000 |
| 00880304672147 | K142746 | 000 |
| 00880304672130 | K142746 | 000 |
| 00880304672123 | K142746 | 000 |
| 00880304672116 | K142746 | 000 |
| 00880304672109 | K142746 | 000 |
| 00880304672192 | K142746 | 000 |