The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Bone Pin.
| Device ID | K990291 |
| 510k Number | K990291 |
| Device Name: | LACTOSORB BONE PIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Michelle L Mckinley |
| Correspondent | Michelle L Mckinley BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-29 |
| Decision Date | 1999-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304424272 | K990291 | 000 |
| 00880304419360 | K990291 | 000 |
| 00880304419353 | K990291 | 000 |
| 00880304419346 | K990291 | 000 |
| 00880304419339 | K990291 | 000 |
| 00880304419322 | K990291 | 000 |
| 00880304419315 | K990291 | 000 |
| 00880304419308 | K990291 | 000 |
| 00880304419292 | K990291 | 000 |
| 00880304419285 | K990291 | 000 |
| 00880304419261 | K990291 | 000 |
| 00880304419254 | K990291 | 000 |
| 00880304419247 | K990291 | 000 |
| 00880304419377 | K990291 | 000 |
| 00880304419384 | K990291 | 000 |
| 00880304424135 | K990291 | 000 |
| 00880304424265 | K990291 | 000 |
| 00880304424258 | K990291 | 000 |
| 00880304424241 | K990291 | 000 |
| 00880304424234 | K990291 | 000 |
| 00880304424227 | K990291 | 000 |
| 00880304424210 | K990291 | 000 |
| 00880304424203 | K990291 | 000 |
| 00880304424197 | K990291 | 000 |
| 00880304424180 | K990291 | 000 |
| 00880304424166 | K990291 | 000 |
| 00880304424159 | K990291 | 000 |
| 00880304424142 | K990291 | 000 |
| 00880304377325 | K990291 | 000 |