The following data is part of a premarket notification filed by Biomedical Ent., Inc. with the FDA for Memograph; Osstaple - Orthopedic Uses For Small Bone And Fragment Fixation For The Memograph Staple System.
| Device ID | K001354 |
| 510k Number | K001354 |
| Device Name: | MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio, TX 78245 |
| Contact | W. Casey Fox |
| Correspondent | W. Casey Fox BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio, TX 78245 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-28 |
| Decision Date | 2001-03-13 |