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FDA 510(k)

TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD

K-Number: K880215 · 1988-02-18

ApplicantWarsaw Orthopedic, Inc.
Decision Date1988-02-18
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD 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 1988-02-18 under 510(k) number K880215. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD?

TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD is a medical device that received FDA 510(k) clearance on 1988-02-18. The listed applicant is Warsaw Orthopedic, Inc.. The 510(k) number is K880215.

When did TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD receive FDA 510(k) clearance?

TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD received FDA 510(k) clearance on 1988-02-18, under 510(k) number K880215.

Who is the listed applicant for TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD?

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 TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD?

The FDA product code for TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD is KWP.

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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 CLOTHINGK883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATEK883783TSRH SACRAL SPINAL SCREWK880211TSRH H/M HOOK HOLDERK880212TSRH H/M HOOK HOLDER W/ROD MOVERK880214TSRH H/M TORQUE LIMITING WRENCH

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Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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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