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510(k) K760325

SURGICAL INSTRUMENTS, ORTHOPEDIC by Depuy, Inc. — Product Code HTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1976
Date Received
July 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
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Other clearances for product code HTX

  • K874954 — MANUAL RONGEUR (December 30, 1987)
  • K841620 — FRONT RADIUS CUTTER (September 20, 1984)
  • K841621 — BACK RADIUS CUTTER (September 20, 1984)
  • K780397 — ORTHOPEDIC FORCEPS (March 22, 1978)