The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Leibinger - Luhr Small Orthopedic Bone Screws.
| Device ID | K963739 |
| 510k Number | K963739 |
| Device Name: | LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Contact | Andrew B Rogers |
| Correspondent | Andrew B Rogers HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-17 |
| Decision Date | 1997-01-22 |
| Summary: | summary |