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510(k) K031318

TRAXIS CEMENT RESTRICTOR by Spinal Concepts, Inc. — Product Code JDK

Clearance Details

Decision
SESU ()
Decision Date
August 22, 2003
Date Received
April 25, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Cement Restrictor
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

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  • K051836 — SKELITE RESORBABLE CEMENT RESTRICTOR (November 21, 2005)
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  • K052367 — SCIENT'X CEMENT RESTRICTOR (October 5, 2005)
  • K041382 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (June 17, 2005)