StageOne™ Shoulder Cement Spacer Molds

Bone Cement, Antibiotic

Biomet, Inc.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Stageone™ Shoulder Cement Spacer Molds.

Pre-market Notification Details

Device IDK221968
510k NumberK221968
Device Name:StageOne™ Shoulder Cement Spacer Molds
ClassificationBone Cement, Antibiotic
Applicant Biomet, Inc. 56 East Bell Drive, P.O. Box 587 Warsaw,  IN  46581
ContactNeha Sreenath
CorrespondentNeha Sreenath
Biomet, Inc. 56 East Bell Drive, P.O. Box 587 Warsaw,  IN  46581
Product CodeMBB  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-05
Decision Date2022-09-15

Trademark Results [StageOne]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STAGEONE
STAGEONE
97373805 not registered Live/Pending
Clean Victory, LLC
2022-04-21
STAGEONE
STAGEONE
85332053 4083371 Dead/Cancelled
Stageone Sports
2011-05-27
STAGEONE
STAGEONE
75611920 2491157 Dead/Cancelled
MORINAGA MILK INDUSTRY CO., LTD.
1998-12-24

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.