K001353 is an FDA 510(k) clearance for the MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM. This device is classified as a Fastener, Plate, Cranioplasty (Class II - Special Controls, product code HBW).
Submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on March 13, 2001, 319 days after receiving the submission on April 28, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5360.
| 510(k) Number | K001353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2000 |
| Decision Date | March 13, 2001 |
| Days to Decision | 319 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBW — Fastener, Plate, Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5360 |