The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Scarf Thread-head (tm) Head Screw.
| Device ID | K971070 |
| 510k Number | K971070 |
| Device Name: | SCARF THREAD-HEAD (TM) HEAD SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | LANDOS, INC. 101 LINDENWOOD DRIVE,SUITE 110 Malvern, PA 19355 |
| Contact | Kath Laffan |
| Correspondent | Kath Laffan LANDOS, INC. 101 LINDENWOOD DRIVE,SUITE 110 Malvern, PA 19355 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1997-07-09 |
| Summary: | summary |