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

Knee Arthroplasty Implantation System

21 CFR 888.3560 / Orthopedic
FDA source (opens on fda.gov)

OOG is the FDA product code for Knee Arthroplasty Implantation System, a class II device type, regulated under 21 CFR 888.3560. FDA's definition for this code reads: "Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
OOG
Device name
Knee Arthroplasty Implantation System
FDA definition
Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
3

Clearances, product code OOG

By decision year
2 clearances under product code OOG with a decision year between 2021 and 2023, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OOG by decision year
YearClearances
20211
20231

Applicants with the most clearances

Product code OOG
Applicants holding the most 510(k) clearances under product code OOG
ApplicantClearances
ConforMIS, Inc.1
Enhatch, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order