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510(k) K823473

POROCOAT MARK IV ELBOW by Depuy, Inc. — Product Code JDB

K823473 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "POROCOAT MARK IV ELBOW". The FDA issued a decision of Substantially Equivalent on January 20, 1983. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1983
Date Received
November 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Semi-Constrained, Cemented
Device Class
Class II
Regulation Number
888.3160
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 JDB

  • K222807 — TEMA Elbow system - Line extension (October 26, 2022)
  • K193247 — LATITUDE EV™ Total Elbow Arthroplasty (August 5, 2020)
  • K182461 — LATITUDE EV Total Elbow Arthroplasty (December 27, 2018)
  • K171010 — Latitude EV Total Elbow Arthroplasty (August 31, 2017)
  • K102180 — RHEAD RADIAL HEAD EXTENDED STEMS (December 20, 2010)
  • K100562 — LATITUDE ELBOW PROSTHESIS (June 29, 2010)
  • K070787 — LATITUDE ELBOW PROTHESIS (August 24, 2007)
  • K070236 — SBI LATERAL RADIO CAPITELLUM (February 21, 2007)
  • K060438 — RHS (April 18, 2006)
  • K060038 — SBI RADIO-CAPITELLAR IMPLANT (March 30, 2006)

FDA data resources