The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Trauma Plating System.
| Device ID | K971870 |
| 510k Number | K971870 |
| 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 | Mary Verstynen |
| Correspondent | Mary Verstynen 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 | 1997-05-21 |
| Decision Date | 1997-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036073787 | K971870 | 000 |
| 00841036067465 | K971870 | 000 |