The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Trauma Plating System.
| Device ID | K992355 |
| 510k Number | K992355 |
| Device Name: | LACTOSORB TRAUMA PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-14 |
| Decision Date | 1999-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036195304 | K992355 | 000 |
| 00841036077099 | K992355 | 000 |
| 00841036070151 | K992355 | 000 |
| 00841036055752 | K992355 | 000 |
| 00841036054670 | K992355 | 000 |
| 00841036054663 | K992355 | 000 |
| 00888233025416 | K992355 | 000 |
| 00888233025409 | K992355 | 000 |
| 00888233025331 | K992355 | 000 |
| 00888233025270 | K992355 | 000 |
| 00888233025263 | K992355 | 000 |
| 00888233025256 | K992355 | 000 |
| 00888233025249 | K992355 | 000 |
| 00888233025232 | K992355 | 000 |
| 00841036077105 | K992355 | 000 |
| 00841036078188 | K992355 | 000 |
| 00841036082185 | K992355 | 000 |
| 00841036195298 | K992355 | 000 |
| 00841036195281 | K992355 | 000 |
| 00841036195274 | K992355 | 000 |
| 00841036195267 | K992355 | 000 |
| 00841036195250 | K992355 | 000 |
| 00841036195212 | K992355 | 000 |
| 00841036125554 | K992355 | 000 |
| 00841036123260 | K992355 | 000 |
| 00841036092078 | K992355 | 000 |
| 00841036085704 | K992355 | 000 |
| 00841036085698 | K992355 | 000 |
| 00841036085681 | K992355 | 000 |
| 00841036082239 | K992355 | 000 |
| 00888233025225 | K992355 | 000 |