The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Hand System.
| Device ID | K991763 |
| 510k Number | K991763 |
| Device Name: | LACTOSORB HAND SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-24 |
| Decision Date | 1999-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304424548 | K991763 | 000 |
| 00880304419650 | K991763 | 000 |
| 00880304419667 | K991763 | 000 |
| 00880304419674 | K991763 | 000 |
| 00880304419681 | K991763 | 000 |
| 00880304419698 | K991763 | 000 |
| 00880304419704 | K991763 | 000 |
| 00880304424487 | K991763 | 000 |
| 00880304424494 | K991763 | 000 |
| 00880304424500 | K991763 | 000 |
| 00880304424517 | K991763 | 000 |
| 00880304424524 | K991763 | 000 |
| 00880304424531 | K991763 | 000 |
| 00880304419643 | K991763 | 000 |