K014148 is an FDA 510(k) clearance for the SELF-DRILLING RADIOGRAPHIC MARKER, a Marker, Radiographic, Implantable (Class II — Special Controls, product code NEU), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 17, 2002, 30 days after receiving the submission on December 18, 2001. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K014148 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2001 |
| Decision Date | January 17, 2002 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEU — Marker, Radiographic, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4300 |