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FDA 510(k)

Sniper Staple System

K-Number: K162354 · 2017-04-20

ApplicantTrilliant Surgical, Ltd.
Decision Date2017-04-20
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sniper Staple System is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical, Ltd.. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K162354. 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 Sniper Staple System?

Sniper Staple System is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Trilliant Surgical, Ltd.. The 510(k) number is K162354.

When did Sniper Staple System receive FDA 510(k) clearance?

Sniper Staple System received FDA 510(k) clearance on 2017-04-20, under 510(k) number K162354.

Who is the listed applicant for Sniper Staple System?

The FDA 510(k) record lists Trilliant Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sniper Staple System?

The FDA product code for Sniper Staple System is JDR.

Other records listing Trilliant Surgical, Ltd. 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.

K212378Arsenal Ankle Plating SystemK191009Arsenal Plating SystemK181898Two-Step Implant SystemK172405SNIPER STAPLE SYSTEM, NON-STERILEK172178Minimally Invasive Bunion Plating SystemK160177Gridlock Ankle Plating 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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