The following data is part of a premarket notification filed by Orthopedic Designs, Inc. with the FDA for Odi Ultimate Compression Hip Screw.
| Device ID | K984331 |
| 510k Number | K984331 |
| Device Name: | ODI ULTIMATE COMPRESSION HIP SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ORTHOPEDIC DESIGNS, INC. 6971 1ST. AVE. NORTH St. Petersburg, FL 33710 -8303 |
| Contact | Jeff Godsted |
| Correspondent | Jeff Godsted ORTHOPEDIC DESIGNS, INC. 6971 1ST. AVE. NORTH St. Petersburg, FL 33710 -8303 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-03 |
| Decision Date | 1999-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B058THS0040261 | K984331 | 000 |
| B058THS0450461 | K984331 | 000 |
| B058THS0450481 | K984331 | 000 |
| B058THS0450501 | K984331 | 000 |
| B058THS0450521 | K984331 | 000 |
| B058THS0450541 | K984331 | 000 |
| B058THS0450561 | K984331 | 000 |
| B058THS1270651 | K984331 | 000 |
| B058THS1270701 | K984331 | 000 |
| B058THS0450441 | K984331 | 000 |
| B058THS0450421 | K984331 | 000 |
| B058THS0450401 | K984331 | 000 |
| B058THS0040321 | K984331 | 000 |
| B058THS0450261 | K984331 | 000 |
| B058THS0450281 | K984331 | 000 |
| B058THS0450301 | K984331 | 000 |
| B058THS0450321 | K984331 | 000 |
| B058THS0450341 | K984331 | 000 |
| B058THS0450361 | K984331 | 000 |
| B058THS0450381 | K984331 | 000 |
| B058THS1270751 | K984331 | 000 |
| B058THS1270801 | K984331 | 000 |
| B058THS1270851 | K984331 | 000 |
| B058THS1353831 | K984331 | 000 |
| B058THS1353841 | K984331 | 000 |
| B058THS1353861 | K984331 | 000 |
| B058THS1353881 | K984331 | 000 |
| B058THS1403841 | K984331 | 000 |
| B058THS1453841 | K984331 | 000 |
| B058THS1502541 | K984331 | 000 |
| B058THS1503841 | K984331 | 000 |
| B058THS1353821 | K984331 | 000 |
| B058THS1352541 | K984331 | 000 |
| B058THS1303841 | K984331 | 000 |
| B058THS1270901 | K984331 | 000 |
| B058THS1270951 | K984331 | 000 |
| B058THS1271001 | K984331 | 000 |
| B058THS1271051 | K984331 | 000 |
| B058THS1271101 | K984331 | 000 |
| B058THS1271151 | K984331 | 000 |
| B058THS1271201 | K984331 | 000 |
| B058THS1271251 | K984331 | 000 |
| B058THS1503861 | K984331 | 000 |