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FDA 510(k)

KNEE PROSTHESIS DRIVER

K-Number: K915776 · 1992-06-11

ApplicantKim-Med, Inc.
Decision Date1992-06-11
Product CodeHWR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KNEE PROSTHESIS DRIVER is the device name listed in this FDA 510(k) record. The listed applicant is Kim-Med, Inc.. It received FDA 510(k) clearance on 1992-06-11 under 510(k) number K915776. 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 KNEE PROSTHESIS DRIVER?

KNEE PROSTHESIS DRIVER is a medical device that received FDA 510(k) clearance on 1992-06-11. The listed applicant is Kim-Med, Inc.. The 510(k) number is K915776.

When did KNEE PROSTHESIS DRIVER receive FDA 510(k) clearance?

KNEE PROSTHESIS DRIVER received FDA 510(k) clearance on 1992-06-11, under 510(k) number K915776.

Who is the listed applicant for KNEE PROSTHESIS DRIVER?

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

What is the FDA product code for KNEE PROSTHESIS DRIVER?

The FDA product code for KNEE PROSTHESIS DRIVER is HWR.

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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.

K875054ACROMED ADS BONE NAIL DRIVERBuckman Co., Inc.K870848SCHULTZ METACARPAL COMPONENT DRIVERWarsaw Orthopedic, Inc.K870847SCHULTZ PHALANGEAL COMPONENT DRIVERWarsaw Orthopedic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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