The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Short Citation Femoral Stem.
Device ID | K053528 |
510k Number | K053528 |
Device Name: | SHORT CITATION FEMORAL STEM |
Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Tiffani Rogers |
Correspondent | Tiffani Rogers STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | MEH |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-19 |
Decision Date | 2006-01-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613154316120 | K053528 | 000 |
07613154316014 | K053528 | 000 |
07613154316007 | K053528 | 000 |
07613154315994 | K053528 | 000 |
07613154315987 | K053528 | 000 |
07613154315970 | K053528 | 000 |
07613154315963 | K053528 | 000 |
07613154315956 | K053528 | 000 |
07613154315949 | K053528 | 000 |
07613154316021 | K053528 | 000 |
07613154316038 | K053528 | 000 |
07613154316113 | K053528 | 000 |
07613154316106 | K053528 | 000 |
07613154316090 | K053528 | 000 |
07613154316083 | K053528 | 000 |
07613154316076 | K053528 | 000 |
07613154316069 | K053528 | 000 |
07613154316052 | K053528 | 000 |
07613154316045 | K053528 | 000 |
07613154315932 | K053528 | 000 |