SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM— 510(k) K102090
Substantially EquivalentSpine Smith Partners L.P.
FDA 510(k) clearance K102090 for SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM, Substantially Equivalent on 2010-09-30. Applicant: Spine Smith Partners L.P.. Device class: 2.
Clearance details
- Applicant
- Spine Smith Partners L.P.
- 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
- Special
- Location
- Austin, TX, US
Recent devices under product code OVD
view allMore clearances from Spine Smith Partners L.P.
view allAdverse 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 K102090
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 K102090.
Data sourced from openFDA. This site is unofficial and independent of the FDA.