The following data is part of a premarket notification filed by Leibinger L.p. with the FDA for Spinal Marker.
| Device ID | K944188 |
| 510k Number | K944188 |
| Device Name: | SPINAL MARKER |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | LEIBINGER L.P. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Contact | Andrew B Rogers |
| Correspondent | Andrew B Rogers LEIBINGER L.P. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1995-04-13 |