The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexmedics Retract Orth Probe, Pettine Bone Probe.
| Device ID | K912843 |
| 510k Number | K912843 |
| Device Name: | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE |
| Classification | Probe |
| Applicant | FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401 |
| Contact | Timothy Ley |
| Correspondent | Timothy Ley FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401 |
| Product Code | HXB |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-26 |
| Decision Date | 1991-09-24 |