510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QBOClass II

Instruments Designed For Press-Fit Osteochondral Implants

21 CFR 888.4505 / Orthopedic
FDA source (opens on fda.gov)

QBO is the FDA product code for Instruments Designed For Press-Fit Osteochondral Implants, a class II device type, regulated under 21 CFR 888.4505. FDA's definition for this code 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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QBO
Device name
Instruments Designed For Press-Fit Osteochondral Implants
FDA definition
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.
Regulation
21 CFR 888.4505
Device class
Class II
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QBO

By decision year
2 clearances under product code QBO with a decision year between 2018 and 2019, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QBO by decision year
YearClearances
20181
20191

Applicants with the most clearances

Product code QBO
Applicants holding the most 510(k) clearances under product code QBO
ApplicantClearances
Cartiva, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order