The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Twist-off (tm) Screw.
| Device ID | K971069 |
| 510k Number | K971069 |
| Device Name: | TWIST-OFF (TM) 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 |