The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Rapidfire Self Drilling Screws.
| Device ID | K031751 |
| 510k Number | K031751 |
| Device Name: | RAPIDFIRE 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 | 2003-06-05 |
| Decision Date | 2003-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036092849 | K031751 | 000 |
| 00841036061012 | K031751 | 000 |
| 00841036062248 | K031751 | 000 |
| 00841036063290 | K031751 | 000 |
| 00841036063306 | K031751 | 000 |
| 00841036063399 | K031751 | 000 |
| 00841036080419 | K031751 | 000 |
| 00841036084189 | K031751 | 000 |
| 00841036084721 | K031751 | 000 |
| 00841036085032 | K031751 | 000 |
| 00841036085049 | K031751 | 000 |
| 00841036059149 | K031751 | 000 |