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510(k) K943277

LINK SADDLE PROTHESIS by Turnkey Intergration USA, Inc.

K943277 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "LINK SADDLE PROTHESIS". The FDA issued a decision of Substantially Equivalent on January 26, 1995. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1995
Date Received
July 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K943986 — LINK ENDO MODEL REVISION CUP (July 5, 1995)
  • K951355 — LINK SADDLE PROTHESIS (May 25, 1995)
  • K950397 — SYSTEM 22 VALVE (April 14, 1995)

FDA data resources