510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K181348Substantially Equivalent

Cartiva SCI Disposable Instrumentation Set

Cartiva, Inc., Alpharetta GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181348 is the FDA 510(k) clearance record for Cartiva SCI Disposable Instrumentation Set, a class II device, cleared for Cartiva, Inc. on under FDA product code QBO (Instruments Designed For Press-Fit Osteochondral Implants). FDA's definition for product code QBO reads: "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". FDA records list 3 510(k) clearances for Cartiva, Inc., from to . As of , FDA records show no recalls naming K181348.

Clearance record

Decision date
Received
(30 days to decision)
Product code
QBO Instruments Designed For Press-Fit Osteochondral Implants
Regulation
21 CFR 888.4505
Device class
Class II
Review panel
Orthopedic
Applicant
Cartiva, Inc. 6120 Windward Pkwy. Suite 220, Alpharetta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBO

Trailing 12 months

FDA records hold no clearances under product code QBO in the trailing twelve months.

FDA records show no clearances under product code QBO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QBO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260