The following data is part of a premarket notification filed by Orthopedic Designs, Inc. with the FDA for Ultimate Compression Screw System.
Device ID | K972722 |
510k Number | K972722 |
Device Name: | ULTIMATE COMPRESSION SCREW SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | ORTHOPEDIC DESIGNS, INC. 5501-D AIRPORT BLVD. Tampa, FL 33634 |
Contact | Randy Lawson |
Correspondent | Randy Lawson ORTHOPEDIC DESIGNS, INC. 5501-D AIRPORT BLVD. Tampa, FL 33634 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-21 |
Decision Date | 1998-01-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ULTIMATE COMPRESSION SCREW SYSTEM 75253325 not registered Dead/Abandoned |
ORTHOPEDIC DESIGNS, INC. 1997-03-07 |