Fastforward
FDA 510(k) K141420 · MedShape, Inc.
510(k) numberK141420
Submission
- Device name
- Fastforward
- Applicant
- MedShape, Inc.
Atlanta, GA, US - Received
- May 29, 2014
- Decision date
- December 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Fastforward cleared by the FDA?
Fastforward (K141420) received a 510(k) decision of Substantially Equivalent on December 18, 2014, 203 days after the submission was received.
What is the product code of K141420?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.