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510(k) K061144

DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT by DePuy Orthopaedics, Inc. — Product Code MBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2006
Date Received
April 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Antibiotic
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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Other clearances for product code MBB

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  • K213287 — StageOne Knee Cement Spacer Molds (September 2, 2022)
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