FDA 510(k)

SPECTRON METAL BACK ACETABULAR COMPONENT

K-Number: K823729 · 1983-01-21

Decision Date1983-01-21

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SPECTRON METAL BACK ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Richard'S Medical Equip., Inc.. It received FDA 510(k) clearance on 1983-01-21 under 510(k) number K823729. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRON METAL BACK ACETABULAR COMPONENT?

SPECTRON METAL BACK ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1983-01-21. The listed applicant is Richard'S Medical Equip., Inc.. The 510(k) number is K823729.

When did SPECTRON METAL BACK ACETABULAR COMPONENT receive FDA 510(k) clearance?

SPECTRON METAL BACK ACETABULAR COMPONENT received FDA 510(k) clearance on 1983-01-21, under 510(k) number K823729.

Who is the listed applicant for SPECTRON METAL BACK ACETABULAR COMPONENT?

The FDA 510(k) record lists Richard'S Medical Equip., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRON METAL BACK ACETABULAR COMPONENT?

The FDA product code for SPECTRON METAL BACK ACETABULAR COMPONENT is JDI.

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Other records listing Richard'S Medical Equip., Inc. as applicant

K830793PATIENT GUIDED ELBOW & SHOULDER EXERC K823837RMC TOTAL KNEE SYSTEM K823723SPECTRON PROXIMAL FEMORAL PROSTHESIS K823724SPECTRON NECK REPLACEMENT PROSTHESIS K823726SPECTRON CONVERSION ENDOPROSTHESIS CUP K823722SPECTRON LONG, STRAIGHT FEMORAL PROSTHES

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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.