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FDA 510(k)

TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE

K-Number: K883784 · 1989-04-06

ApplicantWarsaw Orthopedic, Inc.
Decision Date1989-04-06
Product CodeLYQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE 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 1989-04-06 under 510(k) number K883784. The device is classified under product code LYQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE?

TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE is a medical device that received FDA 510(k) clearance on 1989-04-06. The listed applicant is Warsaw Orthopedic, Inc.. The 510(k) number is K883784.

When did TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE receive FDA 510(k) clearance?

TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE received FDA 510(k) clearance on 1989-04-06, under 510(k) number K883784.

Who is the listed applicant for TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE?

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 ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE?

The FDA product code for TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE is LYQ.

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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 SCREWK880211TSRH H/M HOOK HOLDERK880212TSRH H/M HOOK HOLDER W/ROD MOVERK880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL RODK880214TSRH H/M TORQUE LIMITING WRENCH

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Related Devices (Code: LYQ)

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.

K893415TRANS-ORAL DEPTH GAUGERuggles Corp.K882871CASF DRILL GUIDE DG 170Terray Manufacturing, 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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