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510(k) K960534

METALLIC SPHERICAL CMC IMPLANT by Wrightmedicaltechnologyinc — Product Code KYI

K960534 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "METALLIC SPHERICAL CMC IMPLANT". The FDA issued a decision of Substantially Equivalent on February 6, 1997. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1997
Date Received
February 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Trapezium
Device Class
Class II
Regulation Number
888.3770
Review Panel
OR
Submission Type

Other clearances by Wrightmedicaltechnologyinc

  • K222835 — Prophecy Preoperative Navigation Alignment System (January 27, 2023)
  • K213342 — PRO-DENSE LoVisc Bone Graft Substitute (January 5, 2022)
  • K212996 — Sterile PHALINX Hammertoe System (November 16, 2021)
  • K202815 — PROPHECY Preoperative Navigation Alignment System (March 10, 2021)
  • K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System (January 8, 2021)
  • K200507 — PRO-DENSE LoVisc Bone Graft Substitute (October 21, 2020)
  • K193067 — The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISIO (June 8, 2020)
  • K191393 — INFINITY Total Ankle System, INBONE Total Ankle System (August 22, 2019)
  • K190970 — PROSTEP™ TBI™ (Tailors Bunion Implant) System (August 13, 2019)
  • K183620 — PROSTEP TBC Implant System (June 6, 2019)

Other clearances for product code KYI

  • K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (December 2, 2020)
  • K180744 — Stablyx CMC Arthroplasty Implant System (April 11, 2018)
  • K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 (December 30, 2011)
  • K112278 — ASCENSION NUGRIP CMC IMPLANT (November 4, 2011)
  • K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS (December 15, 2009)
  • K061956 — ARTELON STT SPACER (June 7, 2007)
  • K061954 — ARTELON CMC SPACER ARTHRO (June 1, 2007)
  • K061451 — ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (August 11, 2006)
  • K061089 — MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 1 (June 20, 2006)
  • K060386 — NEXA CARPO METACARPAL IMPLANT (May 10, 2006)

FDA data resources