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510(k) K200587

VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder by Orthosensor, Inc. — Product Code ONN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2020
Date Received
March 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraoperative Orthopedic Joint Assessment Aid
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Measurement and interpretation of orthopedic joint information.

Other clearances by Orthosensor, Inc.

  • K200665 — VERASENSE for Stryker Triathlon (April 12, 2020)
  • K193580 — VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet (April 1, 2020)
  • K180459 — VERASENSE for Zimmer Biomet Persona (June 7, 2018)
  • K150372 — VERASENSE Knee System (April 15, 2016)
  • K131767 — ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM (November 8, 2013)
  • K130380 — ORTHOSENSOR KNEE BALANCER (June 13, 2013)
  • K090474 — ORTHOREX INTRA-OPERATIVE LOAD SENSOR (October 19, 2009)

Other clearances for product code ONN

  • K252524 — Quadsense (Quadsense and Quadsense Pro) (September 9, 2025)
  • K241298 — QUADSENSE (October 4, 2024)
  • K242616 — Lantern® Hip (October 3, 2024)
  • K220830 — TrueBalance™ Surgical System (September 15, 2022)
  • K200665 — VERASENSE for Stryker Triathlon (April 12, 2020)
  • K193580 — VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet (April 1, 2020)
  • K180459 — VERASENSE for Zimmer Biomet Persona (June 7, 2018)
  • K162237 — XO1 Knee Balancing System (April 25, 2017)
  • K150372 — VERASENSE Knee System (April 15, 2016)
  • K132104 — ELIBRA SOFT-TISSUE FORCE SENSOR (March 21, 2014)