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 |