The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Rapidflap.
| Device ID | K003281 |
| 510k Number | K003281 |
| Device Name: | LACTOSORB RAPIDFLAP |
| Classification | Plate, Bone |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Carol Lauster |
| Correspondent | Carol Lauster BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-19 |
| Decision Date | 2001-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036053864 | K003281 | 000 |