510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162525Substantially Equivalent

Oniko nail brace

Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti, Cankaya, TR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162525 is the FDA 510(k) clearance record for Oniko nail brace, cleared for Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti on under FDA product code MQZ (Prosthesis, Nail). FDA records list one 510(k) clearance for Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti. As of , FDA records show no recalls naming K162525.

Clearance record

Decision date
Received
(593 days to decision)
Product code
MQZ Prosthesis, Nail
Device class
Unclassified
Review panel
Unknown
Applicant
Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti Resit Galip Cad. No: 124/10 Gop, Cankaya, TR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQZ

Trailing 12 months

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

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