The following data is part of a premarket notification filed by Orthopedic Designs, Inc. with the FDA for Odi 7.0mm Cannulated Screw System.
| Device ID | K030619 |
| 510k Number | K030619 |
| Device Name: | ODI 7.0MM CANNULATED SCREW SYSTEM |
| Classification | Washer, Bolt Nut |
| Applicant | ORTHOPEDIC DESIGNS, INC. 6965 1ST. AVE. NORTH St. Petersburg, FL 33710 -8303 |
| Contact | Patrick J Cosgrove |
| Correspondent | Patrick J Cosgrove ORTHOPEDIC DESIGNS, INC. 6965 1ST. AVE. NORTH St. Petersburg, FL 33710 -8303 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-27 |
| Decision Date | 2003-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B058CSS7021101 | K030619 | 000 |
| B058CSS7020601 | K030619 | 000 |
| B058CSS7020651 | K030619 | 000 |
| B058CSS7020701 | K030619 | 000 |
| B058CSS7020751 | K030619 | 000 |
| B058CSS7020801 | K030619 | 000 |
| B058CSS7020851 | K030619 | 000 |
| B058CSS7020901 | K030619 | 000 |
| B058CSS7020951 | K030619 | 000 |
| B058CSS7021001 | K030619 | 000 |
| B058CSS7021051 | K030619 | 000 |
| B058CSS0011371 | K030619 | 000 |