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 ID: K221968
• 510k Number: K221968
• Device Name: StageOne™ Shoulder Cement Spacer Molds
• Classification: Bone Cement, Antibiotic
• Applicant: Biomet, Inc. 56 East Bell Drive, P.O. Box 587 Warsaw, IN 46581
• Contact: Neha Sreenath
• Correspondent: Neha Sreenath; Biomet, Inc. 56 East Bell Drive, P.O. Box 587 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: No
• Date Received: 2022-07-05
• Decision Date: 2022-09-15