510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003033Substantially Equivalent

Scaphix, Staple, Fixation, Bone

Avanta Orthopaedics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003033 is the FDA 510(k) clearance record for SCAPHIX, STAPLE, FIXATION, BONE, a class II device, cleared for Avanta Orthopaedics, Inc. on under FDA product code JDR (Staple, Fixation, Bone). FDA records list 18 510(k) clearances for Avanta Orthopaedics, Inc., from to . As of , FDA records show no recalls naming K003033.

Clearance record

Decision date
Received
(244 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Avanta Orthopaedics, Inc. 9369 Carroll Park Dr., Suite A, San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code JDR

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