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510(k) K070787

LATITUDE ELBOW PROTHESIS by Tornier — Product Code JDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2007
Date Received
March 22, 2007
Clearance Type
Special
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

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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)
  • K070236 — SBI LATERAL RADIO CAPITELLUM (February 21, 2007)
  • K060438 — RHS (April 18, 2006)
  • K060038 — SBI RADIO-CAPITELLAR IMPLANT (March 30, 2006)
  • K050848 — TORNIER ELBOW PROSTHESIS (July 14, 2005)