ARSENAL SPINAL FIXATION SYSTEM— 510(k) K133221
Substantially EquivalentAlphatec Spine, Inc.
FDA 510(k) clearance K133221 for ARSENAL SPINAL FIXATION SYSTEM, Substantially Equivalent on 2014-03-13. Applicant: Alphatec Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Alphatec Spine, Inc.
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code NKB
view all- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from Alphatec Spine, Inc.
view all- 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
- K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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 K133221
K-number listed on FDA's recall record- Z-2249-2017 — Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).
- Z-0592-2017 — Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133221.
Data sourced from openFDA. This site is unofficial and independent of the FDA.