The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Stageone Disposable Cement Spacer Molds For Temporary Hemi-shoulder Prosthesis.
Device ID | K160071 |
510k Number | K160071 |
Device Name: | StageOne Disposable Cement Spacer Molds For Temporary Hemi-Shoulder Prosthesis |
Classification | Bone Cement, Antibiotic |
Applicant | Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
Contact | Carmen Albany |
Correspondent | Heidi Busz Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 |
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 | 2016-01-13 |
Decision Date | 2016-06-16 |
Summary: | summary |