The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Spin Down Rapidflap.
| Device ID | K031034 |
| 510k Number | K031034 |
| Device Name: | SPIN DOWN RAPIDFLAP |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| 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 | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-01 |
| Decision Date | 2003-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036142049 | K031034 | 000 |
| 00841036142032 | K031034 | 000 |
| 00841036142025 | K031034 | 000 |
| 00841036068028 | K031034 | 000 |
| 00841036065492 | K031034 | 000 |
| 00841036058586 | K031034 | 000 |
| 00888233011273 | K031034 | 000 |
| 00888233011259 | K031034 | 000 |
| 00888233011235 | K031034 | 000 |