510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153208Substantially Equivalent

Internal Joint Stabilizer - Elbow

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

K153208 is the FDA 510(k) clearance record for Internal Joint Stabilizer - Elbow, a class II device, cleared for Skeletal Dynamics, LLC on under FDA product code OZI (Internal Hinged Elbow Fixator). FDA's definition for product code OZI reads: "The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved". FDA records list 40 510(k) clearances for Skeletal Dynamics, LLC, from to . As of , FDA records show no recalls naming K153208.

Clearance record

Decision date
Received
(56 days to decision)
Product code
OZI Internal Hinged Elbow Fixator
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Skeletal Dynamics, LLC 8905 SW 87 Ave., Suite 201, Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZI

Trailing 12 months

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

FDA records show no clearances under product code OZI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OZI, 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