The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Reach Femoral Hip Component.
| Device ID | K971824 |
| 510k Number | K971824 |
| Device Name: | REACH FEMORAL HIP COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Deborah M Matarazzo |
| Correspondent | Deborah M Matarazzo BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| 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 | 1997-05-16 |
| Decision Date | 1997-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304000575 | K971824 | 000 |
| 00880304251540 | K971824 | 000 |
| 00880304251557 | K971824 | 000 |
| 00880304251571 | K971824 | 000 |
| 00880304251588 | K971824 | 000 |
| 00880304251595 | K971824 | 000 |
| 00880304251601 | K971824 | 000 |
| 00880304251618 | K971824 | 000 |
| 00880304251625 | K971824 | 000 |
| 00880304251533 | K971824 | 000 |
| 00880304222595 | K971824 | 000 |
| 00880304208506 | K971824 | 000 |
| 00880304007864 | K971824 | 000 |
| 00880304007871 | K971824 | 000 |
| 00880304208438 | K971824 | 000 |
| 00880304208445 | K971824 | 000 |
| 00880304208452 | K971824 | 000 |
| 00880304208476 | K971824 | 000 |
| 00880304208483 | K971824 | 000 |
| 00880304208490 | K971824 | 000 |
| 00880304251632 | K971824 | 000 |
| 00880304839007 | K971824 | 000 |
| 00880304839168 | K971824 | 000 |
| 00880304839175 | K971824 | 000 |
| 00880304839182 | K971824 | 000 |
| 00880304839199 | K971824 | 000 |
| 00880304839205 | K971824 | 000 |
| 00880304839212 | K971824 | 000 |
| 00880304839229 | K971824 | 000 |
| 00880304839236 | K971824 | 000 |
| 00880304839151 | K971824 | 000 |
| 00880304839106 | K971824 | 000 |
| 00880304839090 | K971824 | 000 |
| 00880304839014 | K971824 | 000 |
| 00880304839021 | K971824 | 000 |
| 00880304839038 | K971824 | 000 |
| 00880304839045 | K971824 | 000 |
| 00880304839052 | K971824 | 000 |
| 00880304839069 | K971824 | 000 |
| 00880304839076 | K971824 | 000 |
| 00880304839083 | K971824 | 000 |
| 00880304839243 | K971824 | 000 |