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FDA 510(k)

ORTHOMED ORTHOPAEDIC FIXATION STAPLES

K-Number: K861137 · 1986-04-17

ApplicantBiomedical Exports, Inc.
Decision Date1986-04-17
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOMED ORTHOPAEDIC FIXATION STAPLES is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Exports, Inc.. It received FDA 510(k) clearance on 1986-04-17 under 510(k) number K861137. 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 ORTHOMED ORTHOPAEDIC FIXATION STAPLES?

ORTHOMED ORTHOPAEDIC FIXATION STAPLES is a medical device that received FDA 510(k) clearance on 1986-04-17. The listed applicant is Biomedical Exports, Inc.. The 510(k) number is K861137.

When did ORTHOMED ORTHOPAEDIC FIXATION STAPLES receive FDA 510(k) clearance?

ORTHOMED ORTHOPAEDIC FIXATION STAPLES received FDA 510(k) clearance on 1986-04-17, under 510(k) number K861137.

Who is the listed applicant for ORTHOMED ORTHOPAEDIC FIXATION STAPLES?

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

What is the FDA product code for ORTHOMED ORTHOPAEDIC FIXATION STAPLES?

The FDA product code for ORTHOMED ORTHOPAEDIC FIXATION STAPLES 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 Biomedical Exports, 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.

K860291TUBING CONNECTORS

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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