510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901581Substantially Equivalent

Gsb Elbow

Allo Pro Corp., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901581 is the FDA 510(k) clearance record for GSB ELBOW, a class II device, cleared for Allo Pro Corp. on under FDA product code JDC (Prosthesis, Elbow, Constrained, Cemented). FDA records list 16 510(k) clearances for Allo Pro Corp., from to . As of , FDA records show no recalls naming K901581.

Clearance record

Decision date
Received
(201 days to decision)
Product code
JDC Prosthesis, Elbow, Constrained, Cemented
Regulation
21 CFR 888.3150
Device class
Class II
Review panel
Orthopedic
Applicant
Allo Pro Corp. Post Office Box 14159, Clearwater FL
Third party review
No

Clearances, product code JDC

Trailing 12 months

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

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