The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Self-drilling Radiographic Marker.
| Device ID | K014148 |
| 510k Number | K014148 |
| Device Name: | SELF-DRILLING RADIOGRAPHIC MARKER |
| Classification | Marker, Radiographic, Implantable |
| 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 | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-18 |
| Decision Date | 2002-01-17 |
| Summary: | summary |