510(k) K171444 ยท NKG Posterior Cervical Screw System
YUKON OCT Spinal System
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Aug 8, 2017 |
| Received | May 16, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171444
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2022 | K2M, Inc. Yukon Straight Rod 4.0 x120mm;
Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments. Open, Classified |
KWP | None listed |
| Jan 27, 2021 | K2M, Inc Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System Terminated |
NKG | None listed |
| Jul 24, 2018 | K2M, Inc YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA
3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm,
4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 2 Terminated |
NKG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.