The following data is part of a premarket notification filed by Cintor Orthopaedic Div. with the FDA for Ortron 90* Hip Prosthesis.
Device ID | K802627 |
510k Number | K802627 |
Device Name: | ORTRON 90* HIP PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-23 |
Decision Date | 1980-12-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295242338 | K802627 | 000 |
10603295242321 | K802627 | 000 |
10603295242307 | K802627 | 000 |
10603295242246 | K802627 | 000 |
10603295242208 | K802627 | 000 |
10603295241904 | K802627 | 000 |
10603295241898 | K802627 | 000 |
10603295241881 | K802627 | 000 |
10603295241874 | K802627 | 000 |