510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874643Substantially Equivalent for Some Indications

Kirschner Neer-III Modular Proximal Humerus

Kirschner Medical Corp., Timonium MD / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K874643 is the FDA 510(k) clearance record for KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS, a class II device, cleared for Kirschner Medical Corp. on under FDA product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented). FDA records list 76 510(k) clearances for Kirschner Medical Corp., from to . As of , FDA records show no recalls naming K874643.

Clearance record

Decision date
Received
(54 days to decision)
Product code
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Regulation
21 CFR 888.3690
Device class
Class II
Review panel
Orthopedic
Applicant
Kirschner Medical Corp. 9690 Deereco Rd.D, Timonium MD
Third party review
No

Clearances, product code HSD

Trailing 12 months

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

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