510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K924367Substantially Equivalent

Ogden Anchor

Advanced Surgical Implants, Inc., North Charleston SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924367 is the FDA 510(k) clearance record for OGDEN ANCHOR, a class II device, cleared for Advanced Surgical Implants, Inc. on under FDA product code JDR (Staple, Fixation, Bone). FDA records list one 510(k) clearance for Advanced Surgical Implants, Inc. As of , FDA records show no recalls naming K924367.

Clearance record

Decision date
Received
(332 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Advanced Surgical Implants, Inc. 7410 Cross County Rd., Suite E, North Charleston SC
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