510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K070963Substantially Equivalent

Reunion Ha Fracture Stem

Howmedica Osteonics Corp, Mahwah NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070963 is the FDA 510(k) clearance record for REUNION HA FRACTURE STEM, a class II device, cleared for Howmedica Osteonics Corp. on under FDA product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented). FDA records list 377 510(k) clearances for Howmedica Osteonics Corp., from to . As of , FDA records show one recall naming K070963.

Clearance record

Decision date
Received
(29 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
Howmedica Osteonics Corp. 325 Corporate Dr., Mahwah NJ
510(k) summary
Summary PDF
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