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FDA 510(k)

ORTHOHELIX STAPLE SYSTEM

K-Number: K130832 · 2013-08-15

ApplicantOrthohelix Surgical Designs, Inc.
Decision Date2013-08-15
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOHELIX STAPLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthohelix Surgical Designs, Inc.. It received FDA 510(k) clearance on 2013-08-15 under 510(k) number K130832. 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 ORTHOHELIX STAPLE SYSTEM?

ORTHOHELIX STAPLE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-15. The listed applicant is Orthohelix Surgical Designs, Inc.. The 510(k) number is K130832.

When did ORTHOHELIX STAPLE SYSTEM receive FDA 510(k) clearance?

ORTHOHELIX STAPLE SYSTEM received FDA 510(k) clearance on 2013-08-15, under 510(k) number K130832.

Who is the listed applicant for ORTHOHELIX STAPLE SYSTEM?

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

What is the FDA product code for ORTHOHELIX STAPLE SYSTEM?

The FDA product code for ORTHOHELIX STAPLE SYSTEM is JDR.

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Other records listing Orthohelix Surgical Designs, Inc. as applicant

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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.

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

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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