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510(k) K112278

ASCENSION NUGRIP CMC IMPLANT by Ascension Orthopedic — Product Code KYI

K112278 is an FDA 510(k) premarket notification submitted by Ascension Orthopedic for the device "ASCENSION NUGRIP CMC IMPLANT". The FDA issued a decision of Substantially Equivalent on November 4, 2011. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Ascension Orthopedic has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2011
Date Received
August 9, 2011
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 Ascension Orthopedic

  • K140463 — INTEGRA EXTERNAL FIXATION SYSTEM (October 10, 2014)
  • K131360 — INTEGRA TITANIUM BONE WEDGE (August 7, 2013)
  • K130050 — TITAN REVERSE SHOULDER SYSTEM (June 18, 2013)
  • K112438 — TITAN MODULAR TOTAL SHOULDER SYSTEM (April 11, 2012)
  • K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (April 9, 2012)
  • K111799 — NUGAIT(TM) SUBTALAR IMPLANT SYSTEM (August 19, 2011)

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)
  • 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)
  • K052596 — MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17 (November 15, 2005)

FDA data resources