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FDA 510(k)

SPECTRON PROTRUSIO CUP

K-Number: K823725 · 1983-01-21

ApplicantRichard'S Medical Equip., Inc.
Decision Date1983-01-21
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPECTRON PROTRUSIO CUP 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 K823725. 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 PROTRUSIO CUP?

SPECTRON PROTRUSIO CUP 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 K823725.

When did SPECTRON PROTRUSIO CUP receive FDA 510(k) clearance?

SPECTRON PROTRUSIO CUP received FDA 510(k) clearance on 1983-01-21, under 510(k) number K823725.

Who is the listed applicant for SPECTRON PROTRUSIO CUP?

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 PROTRUSIO CUP?

The FDA product code for SPECTRON PROTRUSIO CUP is JDI.

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Other records listing Richard'S Medical Equip., 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.

K830793PATIENT GUIDED ELBOW & SHOULDER EXERCK823837RMC TOTAL KNEE SYSTEMK823723SPECTRON PROXIMAL FEMORAL PROSTHESISK823724SPECTRON NECK REPLACEMENT PROSTHESISK823726SPECTRON CONVERSION ENDOPROSTHESIS CUPK823722SPECTRON LONG, STRAIGHT FEMORAL PROSTHES

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Related Devices (Code: JDI)

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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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