The following data is part of a premarket notification filed by Biomet Orthopedics Llc. with the FDA for Compress(r) Segmental Humeral Replacement System.
| Device ID | K112905 |
| 510k Number | K112905 |
| Device Name: | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | BIOMET ORTHOPEDICS LLC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET ORTHOPEDICS LLC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBF |
| Subsequent Product Code | JDC |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2012-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304554979 | K112905 | 000 |
| 00887868347061 | K112905 | 000 |
| 00887868347054 | K112905 | 000 |
| 00887868347047 | K112905 | 000 |
| 00887868347030 | K112905 | 000 |
| 00887868347023 | K112905 | 000 |
| 00887868347016 | K112905 | 000 |
| 00887868347009 | K112905 | 000 |
| 00887868346996 | K112905 | 000 |
| 00887868346989 | K112905 | 000 |
| 00887868346972 | K112905 | 000 |
| 00887868346965 | K112905 | 000 |
| 00887868346958 | K112905 | 000 |
| 00887868346941 | K112905 | 000 |
| 00880304509672 | K112905 | 000 |
| 00880304554832 | K112905 | 000 |
| 00880304554962 | K112905 | 000 |
| 00880304554955 | K112905 | 000 |
| 00880304554948 | K112905 | 000 |
| 00880304554931 | K112905 | 000 |
| 00880304554924 | K112905 | 000 |
| 00880304554917 | K112905 | 000 |
| 00880304554900 | K112905 | 000 |
| 00880304554894 | K112905 | 000 |
| 00880304554887 | K112905 | 000 |
| 00880304554870 | K112905 | 000 |
| 00880304554863 | K112905 | 000 |
| 00880304554856 | K112905 | 000 |
| 00880304554849 | K112905 | 000 |
| 00887868346934 | K112905 | 000 |