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510(k) K101475

COMPRESS ANTI-ROTATION SPINDLES by Biomet Manufacturing Corp — Product Code KWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2010
Date Received
May 28, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3330
Review Panel
OR
Submission Type

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