The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lorenz Lactosorb Panels And Fasteners.
| Device ID | K011139 |
| 510k Number | K011139 |
| Device Name: | LORENZ LACTOSORB PANELS AND FASTENERS |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-13 |
| Decision Date | 2001-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036055240 | K011139 | 000 |
| 00841036054915 | K011139 | 000 |
| 00841036054793 | K011139 | 000 |
| 00841036054779 | K011139 | 000 |
| 00841036054762 | K011139 | 000 |
| 00841036054717 | K011139 | 000 |
| 00841036054700 | K011139 | 000 |
| 00841036054687 | K011139 | 000 |