The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz 2.4 Self Drilling Screws.
Device ID | K032228 |
510k Number | K032228 |
Device Name: | LORENZ 2.4 SELF DRILLING SCREWS |
Classification | Screw, Fixation, Bone |
Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Contact | Kim Reed |
Correspondent | Kim Reed WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-21 |
Decision Date | 2003-08-11 |
Summary: | summary |