Endoskeleton TCS Interbody Fusion Device— 510(k) K151596
Substantially EquivalentTitan Spine, LLC
FDA 510(k) clearance K151596 for Endoskeleton TCS Interbody Fusion Device, Substantially Equivalent on 2015-10-09. Applicant: Titan Spine, LLC. Device class: 2.
Clearance details
- Applicant
- Titan Spine, LLC
- 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
- Traditional
- Location
- Mequon, WI, US
Recent devices under product code OVE
view allMore clearances from Titan Spine, LLC
view all- K173535 — Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
- K170399 — Endoskeleton TO Interbody Fusion Device (IBD)
- K163269 — Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device
- K153122 — Endoskeleton(r) TCS System
- K142940 — Endoskeleton TCS System
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 K151596
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 K151596.
Data sourced from openFDA. This site is unofficial and independent of the FDA.