Reprocessed Pins

FDA 510(k) K100707 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK100707

Submission

Device name
Reprocessed Pins
Applicant
Sterilmed, Inc.
Maple Grove, MN, US
Received
March 12, 2010
Decision date
June 25, 2010
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NDM – Pin, Fixation, Threaded, Metallic
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Reprocessed Pins cleared by the FDA?

Reprocessed Pins (K100707) received a 510(k) decision of Substantially Equivalent on June 25, 2010, 105 days after the submission was received.

What is the product code of K100707?

The FDA product code is NDM – Pin, Fixation, Threaded, Metallic, a Class II (moderate risk) device regulated under 21 CFR 888.3040.