510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K930015Substantially Equivalent

Sternal Band

Stony Brook Surgical Innovations, Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930015 is the FDA 510(k) clearance record for STERNAL BAND, a class II device, cleared for Stony Brook Surgical Innovations, Inc. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 2 510(k) clearances for Stony Brook Surgical Innovations, Inc., from to . As of , FDA records show no recalls naming K930015.

Clearance record

Decision date
Received
(135 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Stony Brook Surgical Innovations, Inc. 55 Northern Blvd., Suite 301, Great Neck NY
510(k) summary
Statement
Third party review
No

Clearances, product code JDQ

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