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FDA 510(k)

SCHULTZ PHALANGEAL COMPONENT DRIVER

K-Number: K870847 · 1987-03-13

ApplicantWarsaw Orthopedic, Inc.
Decision Date1987-03-13
Product CodeHWR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCHULTZ PHALANGEAL COMPONENT DRIVER 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 1987-03-13 under 510(k) number K870847. The device is classified under product code HWR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCHULTZ PHALANGEAL COMPONENT DRIVER?

SCHULTZ PHALANGEAL COMPONENT DRIVER is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Warsaw Orthopedic, Inc.. The 510(k) number is K870847.

When did SCHULTZ PHALANGEAL COMPONENT DRIVER receive FDA 510(k) clearance?

SCHULTZ PHALANGEAL COMPONENT DRIVER received FDA 510(k) clearance on 1987-03-13, under 510(k) number K870847.

Who is the listed applicant for SCHULTZ PHALANGEAL COMPONENT DRIVER?

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 SCHULTZ PHALANGEAL COMPONENT DRIVER?

The FDA product code for SCHULTZ PHALANGEAL COMPONENT DRIVER is HWR.

Related Clinical Trials

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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 MOVERK880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD

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Related Devices (Code: HWR)

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.

K915776KNEE PROSTHESIS DRIVERKim-Med, Inc.K875054ACROMED ADS BONE NAIL DRIVERBuckman Co., Inc.K870848SCHULTZ METACARPAL COMPONENT DRIVERWarsaw Orthopedic, 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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