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510(k) K943986

LINK ENDO MODEL REVISION CUP by Turnkey Intergration USA, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1995
Date Received
August 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Turnkey Intergration USA, Inc.

  • K991405 — OMNI-FIX, HUMERAL NAIL (June 29, 1999)
  • K990523 — B2C, ESPACE REVISION CUP SYSTEM (April 30, 1999)
  • K990307 — OMNI-FIX, NAIL SYSTEM (April 1, 1999)
  • K972411 — LINK CEMENT PLUG (August 29, 1997)
  • K970284 — ARTOS, DIPLOS SYSTEM (April 21, 1997)
  • K970084 — LINK CERCLAGE WIRE SYSTEM (March 13, 1997)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K951355 — LINK SADDLE PROTHESIS (May 25, 1995)
  • K950397 — SYSTEM 22 VALVE (April 14, 1995)
  • K940297 — UNIVERSAL WRIST (February 6, 1995)

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