510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K182171Substantially Equivalent

SMV Scientific K-Wire and Pins

Summit Medventures, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182171 is the FDA 510(k) clearance record for SMV Scientific K-Wire and Pins, a class II device, cleared for Summit Medventures on under FDA product code JDW (Pin, Fixation, Threaded). FDA records list 2 510(k) clearances for Summit Medventures, from to . As of , FDA records show no recalls naming K182171.

Clearance record

Decision date
Received
(76 days to decision)
Product code
JDW Pin, Fixation, Threaded
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Summit Medventures 7500 Rialto Blvd., Bldg. 1, Suite 225, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDW

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