The following data is part of a premarket notification filed by Surgicraft Ltd. with the FDA for Stalif Tt.
Device ID | K041617 |
510k Number | K041617 |
Device Name: | STALIF TT |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | SURGICRAFT LTD. 121 W. CHESTNUT ST., #3506 Chicago, IL 60610 |
Contact | Janet M Webb |
Correspondent | Janet M Webb SURGICRAFT LTD. 121 W. CHESTNUT ST., #3506 Chicago, IL 60610 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-06-15 |
Decision Date | 2004-09-08 |
Summary: | summary |