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FDA 510(k)

JAWS(TM) Nitinol Staple System

K-Number: K170923 · 2017-07-24

ApplicantParagon 28
Decision Date2017-07-24
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAWS(TM) Nitinol Staple System is a medical device manufactured by Paragon 28. It received FDA 510(k) clearance on 2017-07-24 under approval number K170923. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAWS(TM) Nitinol Staple System?

JAWS(TM) Nitinol Staple System is a medical device that received FDA 510(k) clearance on 2017-07-24. It is manufactured by Paragon 28. The 510(k) number is K170923.

When was JAWS(TM) Nitinol Staple System approved by the FDA?

JAWS(TM) Nitinol Staple System received FDA 510(k) clearance on 2017-07-24, under approval number K170923.

What company makes JAWS(TM) Nitinol Staple System?

JAWS(TM) Nitinol Staple System is manufactured by Paragon 28.

What is the FDA product code for JAWS(TM) Nitinol Staple System?

The FDA product code for JAWS(TM) Nitinol Staple System is JDR.

Other Devices by Paragon 28

K172886Breakaway Screw System K162241TITAN 3-D™ Wedge System K171715HammerTube System

Related Devices (Code: JDR)

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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.

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