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510(k) K181348

Cartiva SCI Disposable Instrumentation Set by Cartiva, Inc. — Product Code QBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2018
Date Received
May 21, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments Designed For Press-Fit Osteochondral Implants
Device Class
Class II
Regulation Number
888.4505
Review Panel
OR
Submission Type

The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.

Other clearances by Cartiva, Inc.

  • K192156 — Cartiva SCI instrumentation set (September 4, 2019)
  • K142490 — ProxiFuse Hammer Toe Device (December 15, 2014)

Other clearances for product code QBO

  • K192156 — Cartiva SCI instrumentation set (September 4, 2019)