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FDA 510(k)

COMPRESSYN STAPLE

K-Number: K122871 · 2013-02-07

ApplicantDallen Medical, Inc.
Decision Date2013-02-07
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPRESSYN STAPLE is the device name listed in this FDA 510(k) record. The listed applicant is Dallen Medical, Inc.. It received FDA 510(k) clearance on 2013-02-07 under 510(k) number K122871. 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 COMPRESSYN STAPLE?

COMPRESSYN STAPLE is a medical device that received FDA 510(k) clearance on 2013-02-07. The listed applicant is Dallen Medical, Inc.. The 510(k) number is K122871.

When did COMPRESSYN STAPLE receive FDA 510(k) clearance?

COMPRESSYN STAPLE received FDA 510(k) clearance on 2013-02-07, under 510(k) number K122871.

Who is the listed applicant for COMPRESSYN STAPLE?

The FDA 510(k) record lists Dallen Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPRESSYN STAPLE?

The FDA product code for COMPRESSYN STAPLE is JDR.

Related Clinical Trials

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.

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Other records listing Dallen Medical, Inc. 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.

K171473Compressyn™ StapleK132875COMPRESSYN STAPLEK131850TENSYN BANDK130431COMPRESSYN BAND

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.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 Concepts

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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