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510(k) K053339

ALLOFIX ANCHOR by Musculoskeletal Transplant Foundation — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2006
Date Received
December 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

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