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FDA 510(k)

FIXATION STAPLE DRIVER/EXTRACTOR

K-Number: K832884 · 1983-10-20

ApplicantWarsaw Orthopedic, Inc.
Decision Date1983-10-20
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXATION STAPLE DRIVER/EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Warsaw Orthopedic, Inc.. It received FDA 510(k) clearance on 1983-10-20 under 510(k) number K832884. 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 FIXATION STAPLE DRIVER/EXTRACTOR?

FIXATION STAPLE DRIVER/EXTRACTOR is a medical device that received FDA 510(k) clearance on 1983-10-20. The listed applicant is Warsaw Orthopedic, Inc.. The 510(k) number is K832884.

When did FIXATION STAPLE DRIVER/EXTRACTOR receive FDA 510(k) clearance?

FIXATION STAPLE DRIVER/EXTRACTOR received FDA 510(k) clearance on 1983-10-20, under 510(k) number K832884.

Who is the listed applicant for FIXATION STAPLE DRIVER/EXTRACTOR?

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

What is the FDA product code for FIXATION STAPLE DRIVER/EXTRACTOR?

The FDA product code for FIXATION STAPLE DRIVER/EXTRACTOR is JDR.

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Other records listing Warsaw Orthopedic, 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.

K892877CRADLE, HOSPITAL BED CLOTHINGK883783TSRH SACRAL SPINAL SCREWK883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATEK880211TSRH H/M HOOK HOLDERK880212TSRH H/M HOOK HOLDER W/ROD MOVERK880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD

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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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