510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100707Substantially Equivalent

Reprocessed Pins

Sterilmed Inc, Maple Grove MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K100707 is the FDA 510(k) clearance record for REPROCESSED PINS, a class II device, cleared for Sterilmed, Inc. on under FDA product code NDM (Pin, Fixation, Threaded, Metallic). FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show no recalls naming K100707.

Clearance record

Decision date
Received
(105 days to decision)
Product code
NDM Pin, Fixation, Threaded, Metallic
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Sterilmed, Inc. 11400 73rd Ave. N, Maple Grove MN
510(k) summary
Statement
Third party review
No

Clearances, product code NDM

Trailing 12 months

FDA records hold no clearances under product code NDM in the trailing twelve months.

FDA records show no clearances under product code NDM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NDM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260