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510(k) K970284

ARTOS, DIPLOS SYSTEM by Turnkey Intergration USA, Inc. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1997
Date Received
January 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
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)
  • K970084 — LINK CERCLAGE WIRE SYSTEM (March 13, 1997)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K943986 — LINK ENDO MODEL REVISION CUP (July 5, 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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  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)