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510(k) K760325

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

K760325 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "SURGICAL INSTRUMENTS, ORTHOPEDIC". The FDA issued a decision of Substantially Equivalent on August 3, 1976. The device falls under product code HTX (Rongeur), a Class I device regulated under 21 CFR 888.4540. Depuy, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Depuy, Inc.

  • K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS (March 14, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (July 22, 2004)
  • K033959 — LPS (July 1, 2004)
  • K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO (May 28, 2004)
  • K021478 — DELTA SHOULDER (November 18, 2003)
  • K033329 — DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (November 14, 2003)
  • K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (September 26, 2003)
  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
  • K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (September 7, 2001)

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)

FDA data resources