The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Biomet Stage One Disposable Cement Spacer Molds For Temporary Hemi-shoulder Prosthesis.
Device ID | K131135 |
510k Number | K131135 |
Device Name: | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS |
Classification | Bone Cement, Antibiotic |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Carmen Albany |
Correspondent | Carmen Albany BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | MBB |
Subsequent Product Code | HSD |
Subsequent Product Code | KWS |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2013-04-22 |
Decision Date | 2014-01-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304551114 | K131135 | 000 |
00887868543197 | K131135 | 000 |
00887868543203 | K131135 | 000 |
00887868543210 | K131135 | 000 |
00887868543227 | K131135 | 000 |
00880304551008 | K131135 | 000 |
00880304551015 | K131135 | 000 |
00880304551091 | K131135 | 000 |
00880304551107 | K131135 | 000 |
00887868543180 | K131135 | 000 |