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510(k) K192156

Cartiva SCI instrumentation set by Cartiva, Inc. — Product Code QBO

K192156 is an FDA 510(k) premarket notification submitted by Cartiva, Inc. for the device "Cartiva SCI instrumentation set". The FDA issued a decision of Substantially Equivalent on September 4, 2019. The device falls under product code QBO (Instruments Designed For Press-Fit Osteochondral Implants), a Class II device regulated under 21 CFR 888.4505. Cartiva, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2019
Date Received
August 9, 2019
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.

  • K181348 — Cartiva SCI Disposable Instrumentation Set (June 20, 2018)
  • K142490 — ProxiFuse Hammer Toe Device (December 15, 2014)

Other clearances for product code QBO

  • K181348 — Cartiva SCI Disposable Instrumentation Set (June 20, 2018)

FDA data resources