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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 the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28. It received FDA 510(k) clearance on 2017-07-24 under 510(k) 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. The listed applicant is Paragon 28. The 510(k) number is K170923.

When did JAWS(TM) Nitinol Staple System receive FDA 510(k) clearance?

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

Who is the listed applicant for JAWS(TM) Nitinol Staple System?

The FDA 510(k) record lists Paragon 28 as the applicant. This does not by itself establish the device manufacturer.

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 records listing Paragon 28 as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemK262047Grappler Suture Anchor SystemK253886Grappler Suture Anchor PCFD Tether SystemK253591Phantom® Hindfoot TTC/TC Nail SystemK253613Monkey Rings External Ring Fixation SystemK252106External Fixation Mini Rail System

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Related Devices (Code: JDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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