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510(k) K771709

WORRELL TRIAL PATELLA by Depuy, Inc. — Product Code HWT

K771709 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "WORRELL TRIAL PATELLA". The FDA issued a decision of Substantially Equivalent on October 6, 1977. The device falls under product code HWT (Template), a Class I device regulated under 21 CFR 888.4800. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1977
Date Received
September 12, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Template
Device Class
Class I
Regulation Number
888.4800
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 HWT

  • K974406 — ORTHOPLAN (February 18, 1998)
  • K960685 — ORTHODOC PREOPERATIVE PLANNER MODEL 500 (January 17, 1997)
  • K894228 — KRONNER SPHERICAL CUTTERS (July 23, 1990)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K871323 — ARTHROSCOPIC MENISCAL SUTURE SYSTEM (May 1, 1987)
  • K830360 — 3M OSTEOTOMY GUIDE (March 1, 1983)
  • K811205 — MOLDED POLYSULFONE TRIAL PROSTHESIS (May 21, 1981)
  • K781091 — KNEE INSTRUMENTATION, CONDYLAR (July 17, 1978)
  • K771710 — WORRELL PATELLA TEMPLATE (October 6, 1977)

FDA data resources