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

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

21 CFR 888.3660 / Orthopedic
FDA source (opens on fda.gov)

PAO is the FDA product code for Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented, a class II device type, regulated under 21 CFR 888.3660. FDA's definition for this code reads: "Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PAO
Device name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
FDA definition
Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
3

Clearances, product code PAO

By decision year
1 clearance under product code PAO with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PAO by decision year
YearClearances
20201

Applicants with the most clearances

Product code PAO
Applicants holding the most 510(k) clearances under product code PAO
ApplicantClearances
TORNIER Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order