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FDA 510(k)

SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN

K-Number: K862311 · 1986-07-25

ApplicantWarsaw Orthopedic, Inc.
Decision Date1986-07-25
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN 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 1986-07-25 under 510(k) number K862311. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN?

SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN is a medical device that received FDA 510(k) clearance on 1986-07-25. The listed applicant is Warsaw Orthopedic, Inc.. The 510(k) number is K862311.

When did SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN receive FDA 510(k) clearance?

SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN received FDA 510(k) clearance on 1986-07-25, under 510(k) number K862311.

Who is the listed applicant for SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN?

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 SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN?

The FDA product code for SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN is KTT.

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 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

View all 24 devices →

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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