The following data is part of a premarket notification filed by Millennium Medical Technologies, Inc. with the FDA for Hbs Headless Bone Screw.
Device ID | K020791 |
510k Number | K020791 |
Device Name: | HBS HEADLESS BONE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | MILLENNIUM MEDICAL TECHNOLOGIES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
Contact | David W Schlerf |
Correspondent | David W Schlerf MILLENNIUM MEDICAL TECHNOLOGIES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-11 |
Decision Date | 2002-06-06 |
Summary: | summary |