SPECTRON CONVERSION ENDOPROSTHESIS CUP

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

RICHARD'S MEDICAL EQUIP., INC.

The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Spectron Conversion Endoprosthesis Cup.

Pre-market Notification Details

Device IDK823726
510k NumberK823726
Device Name:SPECTRON CONVERSION ENDOPROSTHESIS CUP
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-10
Decision Date1983-03-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03596010079527 K823726 000
03596010079190 K823726 000
03596010079183 K823726 000
03596010079176 K823726 000
03596010079169 K823726 000
03596010411853 K823726 000
03596010409294 K823726 000
03596010306869 K823726 000
03596010306852 K823726 000
03596010306838 K823726 000
03596010196514 K823726 000
03596010196507 K823726 000
03596010196477 K823726 000
03596010196460 K823726 000
03596010196453 K823726 000
03596010196446 K823726 000
03596010079206 K823726 000
03596010079350 K823726 000
03596010079367 K823726 000
03596010079510 K823726 000
03596010079503 K823726 000
03596010079497 K823726 000
03596010079480 K823726 000
03596010079473 K823726 000
03596010079466 K823726 000
03596010079459 K823726 000
03596010079442 K823726 000
03596010079435 K823726 000
03596010079428 K823726 000
03596010079411 K823726 000
03596010079404 K823726 000
03596010079398 K823726 000
03596010079381 K823726 000
03596010079374 K823726 000
03596010196415 K823726 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.