Endoskeleton TCS Interbody Fusion Device— 510(k) K191565
Substantially EquivalentTitan Spine, Inc.
FDA 510(k) clearance K191565 for Endoskeleton TCS Interbody Fusion Device, Substantially Equivalent on 2019-08-06. Applicant: Titan Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Titan Spine, Inc.
- Product code
- Code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mequon, WI, US
Recent devices under product code OVE
view allMore clearances from Titan Spine, Inc.
view all- K191581 — Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
- K192054 — Endoskeleton TAS Plate
- K192018 — Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
- K183557 — Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
Adverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
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 K191565
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 K191565.
Data sourced from openFDA. This site is unofficial and independent of the FDA.