510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K970013Substantially Equivalent

Biorigid Nail Tibia

Aap GmbH and Co. Betriebs KG, 12099 Berlin, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970013 is the FDA 510(k) clearance record for BIORIGID NAIL TIBIA, a class II device, cleared for Aap GmbH and Co. Betriebs KG on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list one 510(k) clearance for Aap GmbH and Co. Betriebs KG. As of , FDA records show no recalls naming K970013.

Clearance record

Decision date
Received
(70 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Aap GmbH and Co. Betriebs KG Lorenzweg 5, 12099 Berlin, DE
510(k) summary
Statement
Third party review
No

Clearances, product code HTY

Trailing 12 months
2 clearances under product code HTY in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTY, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260