510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901456Substantially Equivalent

Orthosorb(r) Absorbable Pin

Johnson & Johnson International, Braintree MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901456 is the FDA 510(k) clearance record for ORTHOSORB(R) ABSORBABLE PIN, a class II device, cleared for Johnson & Johnson International on under FDA product code OVZ (Pin, Fixation, Resorbable, Hard Tissue). FDA's definition for product code OVZ reads: "Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications". FDA records list 10 510(k) clearances for Johnson & Johnson International, from to . As of , FDA records show no recalls naming K901456.

Clearance record

Decision date
Received
(141 days to decision)
Product code
OVZ Pin, Fixation, Resorbable, Hard Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Johnson & Johnson International 100 Bay State Dr., Braintree MA
Third party review
No

Clearances, product code OVZ

Trailing 12 months

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

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