510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092721Substantially Equivalent

Align Radial Head System

Skeletal Dynamics, Inc, Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092721 is the FDA 510(k) clearance record for ALIGN RADIAL HEAD SYSTEM, a class II device, cleared for Skeletal Dynamics, LLC on under FDA product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer). FDA records list 40 510(k) clearances for Skeletal Dynamics, LLC, from to . As of , FDA records show one recall naming K092721.

Clearance record

Decision date
Received
(333 days to decision)
Product code
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation
21 CFR 888.3170
Device class
Class II
Review panel
Orthopedic
Applicant
Skeletal Dynamics, LLC 80 Sheldon Technology Center, Shelton CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWI

Trailing 12 months
1 clearance under product code KWI in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260