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FDA 510(k)

BONE STAPLE(S)

K-Number: K904553 · 1990-12-21

ApplicantSynthes (Usa)
Decision Date1990-12-21
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE STAPLE(S) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1990-12-21 under 510(k) number K904553. 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 BONE STAPLE(S)?

BONE STAPLE(S) is a medical device that received FDA 510(k) clearance on 1990-12-21. The listed applicant is Synthes (Usa). The 510(k) number is K904553.

When did BONE STAPLE(S) receive FDA 510(k) clearance?

BONE STAPLE(S) received FDA 510(k) clearance on 1990-12-21, under 510(k) number K904553.

Who is the listed applicant for BONE STAPLE(S)?

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

What is the FDA product code for BONE STAPLE(S)?

The FDA product code for BONE STAPLE(S) is JDR.

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Other records listing Synthes (Usa) 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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