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FDA 510(k)

TENSTAPLE ORTHOPEDIC STAPLING SYSTEM

K-Number: K896471 · 1990-07-24

ApplicantTenstaple, Inc.
Decision Date1990-07-24
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENSTAPLE ORTHOPEDIC STAPLING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tenstaple, Inc.. It received FDA 510(k) clearance on 1990-07-24 under 510(k) number K896471. 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 TENSTAPLE ORTHOPEDIC STAPLING SYSTEM?

TENSTAPLE ORTHOPEDIC STAPLING SYSTEM is a medical device that received FDA 510(k) clearance on 1990-07-24. The listed applicant is Tenstaple, Inc.. The 510(k) number is K896471.

When did TENSTAPLE ORTHOPEDIC STAPLING SYSTEM receive FDA 510(k) clearance?

TENSTAPLE ORTHOPEDIC STAPLING SYSTEM received FDA 510(k) clearance on 1990-07-24, under 510(k) number K896471.

Who is the listed applicant for TENSTAPLE ORTHOPEDIC STAPLING SYSTEM?

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

What is the FDA product code for TENSTAPLE ORTHOPEDIC STAPLING SYSTEM?

The FDA product code for TENSTAPLE ORTHOPEDIC STAPLING SYSTEM is JDR.

Related Clinical Trials

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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

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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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