The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Orthopedic Salvage System (oss) 9cm Cobalt - Chrome Tibial Bodies.
Device ID | K083827 |
510k Number | K083827 |
Device Name: | ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES |
Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
Contact | Gary Baker |
Correspondent | Gary Baker BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
Product Code | KRO |
CFR Regulation Number | 888.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-23 |
Decision Date | 2009-02-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304840416 | K083827 | 000 |
00880304652217 | K083827 | 000 |
00880304652200 | K083827 | 000 |
00880304652194 | K083827 | 000 |
00880304510081 | K083827 | 000 |