The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Memory Staple (20 Sizes Available).
| Device ID | K964226 |
| 510k Number | K964226 |
| Device Name: | MEMORY STAPLE (20 SIZES AVAILABLE) |
| Classification | Staple, Fixation, Bone |
| Applicant | LANDOS, INC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin, Ph.d. Roc |
| Correspondent | Norman F Estrin, Ph.d. Roc LANDOS, INC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-23 |
| Decision Date | 1997-08-05 |
| Summary: | summary |