IdentiTi ALIF Interbody Systems— 510(k) K232097
Substantially EquivalentAlphatec Spine, Inc.
FDA 510(k) clearance K232097 for IdentiTi ALIF Interbody Systems, Substantially Equivalent on 2023-09-25. 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
- Carlsbad, 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 →
Recalls naming K232097
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232097.
Data sourced from openFDA. This site is unofficial and independent of the FDA.