ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

MED-TEK CORP.

The following data is part of a premarket notification filed by Med-tek Corp. with the FDA for Astel Non-metal Backed Acetabular Cup For Cemented.

Pre-market Notification Details

Device IDK901240
510k NumberK901240
Device Name:ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant MED-TEK CORP. 6535 E. 82ND ST. SUITE 215 Indianapolis,  IN  46250
ContactKenneth Epling
CorrespondentKenneth Epling
MED-TEK CORP. 6535 E. 82ND ST. SUITE 215 Indianapolis,  IN  46250
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-15
Decision Date1990-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024362314 K901240 000
00889024362239 K901240 000
00889024362246 K901240 000
00889024362253 K901240 000
00889024362260 K901240 000
00889024362277 K901240 000
00889024362284 K901240 000
00889024362291 K901240 000
00889024362307 K901240 000
00889024362222 K901240 000

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