SIGN IM Nail
K-Number: K163589 · 2017-07-20
ApplicantSign Fracture Care International
Decision Date2017-07-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SIGN IM Nail is a medical device manufactured by Sign Fracture Care International. It received FDA 510(k) clearance on 2017-07-20 under approval number K163589. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SIGN IM Nail?
SIGN IM Nail is a medical device that received FDA 510(k) clearance on 2017-07-20. It is manufactured by Sign Fracture Care International. The 510(k) number is K163589.
When was SIGN IM Nail approved by the FDA?
SIGN IM Nail received FDA 510(k) clearance on 2017-07-20, under approval number K163589.
What company makes SIGN IM Nail?
SIGN IM Nail is manufactured by Sign Fracture Care International.
What is the FDA product code for SIGN IM Nail?
The FDA product code for SIGN IM Nail is HSB.
Other Devices by Sign Fracture Care International
Related Devices (Code: HSB)
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K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC
K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC
K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.
K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.