ATEC Lateral Navigation Instruments— 510(k) K223765
Substantially EquivalentAlphatec Spine, Inc.
FDA 510(k) clearance K223765 for ATEC Lateral Navigation Instruments, Substantially Equivalent on 2023-03-23. Applicant: Alphatec Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Alphatec Spine, Inc.
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code OLO
view allMore clearances from Alphatec Spine, Inc.
view all- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253216 — IntraOp Alignment System; CONTOUR3D Bending System
- K253615 — Invictus Bands System
- K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
- K252842 — SafeOp 3: Neural Informatix System
Adverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
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 K223765
K-number listed on FDA's recall record- Z-1342-2026 — ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
- Z-1343-2026 — ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223765.
Data sourced from openFDA. This site is unofficial and independent of the FDA.