The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Scarf Thread-head Screw.
| Device ID | K962236 |
| 510k Number | K962236 |
| Device Name: | SCARF THREAD-HEAD SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | LANDOS, INC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin LANDOS, INC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-11 |
| Decision Date | 1996-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868115752 | K962236 | 000 |
| 00887868115745 | K962236 | 000 |
| 08426750013886 | K962236 | 000 |
| 08426750013879 | K962236 | 000 |
| 08426750013862 | K962236 | 000 |
| 08426750013855 | K962236 | 000 |
| 08426750013848 | K962236 | 000 |