SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM— 510(k) K102402
Substantially EquivalentAlphatec Spine, Inc.
FDA 510(k) clearance K102402 for SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM, Substantially Equivalent on 2011-03-30. Applicant: Alphatec Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Alphatec Spine, Inc.
- Product code
- Code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsnad, CA, US
Recent devices under product code OVD
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 OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.