YUKON OCT Spinal System— 510(k) K171444
Substantially EquivalentK2m, Inc.
FDA 510(k) clearance K171444 for YUKON OCT Spinal System, Substantially Equivalent on 2017-08-08. Applicant: K2m, Inc.. Device class: 2.
Clearance details
- Applicant
- K2m, Inc.
- Product code
- Code NKG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3075
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leesburg, VA, US
Recent devices under product code NKG
view allMore clearances from K2m, Inc.
view allAdverse events under product code NKG
product code NKG- Death
- 15
- Injury
- 1,090
- Malfunction
- 529
- Total
- 1,634
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K171444
K-number listed on FDA's recall record- Z-1307-2022 — Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
- Z-0931-2021 — Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
- Z-0110-2020 — 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 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Catalog Numbers 7601-03512, 7601-03514, 7601-03532, 7601-03534, 7601-03538L, 7601-03540L, 7601-04016L, 7601-04018L, 7601-04020L, 7601-04022L, 7601-04024L, 7601-04026L, 7601-04028L, 7601-04030, 7601-05022, 7601-05028, 7601-05030
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171444.
Data sourced from openFDA. This site is unofficial and independent of the FDA.