510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K973420Substantially Equivalent

Clinitex Cast Padding

Clinitex Medical Corp., Huntersville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973420 is the FDA 510(k) clearance record for CLINITEX CAST PADDING, a class I device, cleared for Clinitex Medical Corp. on under FDA product code LGF (Component, Cast). FDA records list 2 510(k) clearances for Clinitex Medical Corp. As of , FDA records show no recalls naming K973420.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LGF Component, Cast
Regulation
21 CFR 888.5940
Device class
Class I
Review panel
Orthopedic
Applicant
Clinitex Medical Corp. 9801 Kincey Ave., Suite 100, Huntersville NC
510(k) summary
Statement
Third party review
No

Clearances, product code LGF

Trailing 12 months

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

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