Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device— 510(k) K173535
Substantially EquivalentTitan Spine, LLC
FDA 510(k) clearance K173535 for Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device, Substantially Equivalent on 2018-02-13. Applicant: Titan Spine, LLC. Device class: 2.
Clearance details
- Applicant
- Titan Spine, LLC
- Product code
- Code ODP
- 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 ODP
view allMore clearances from Titan Spine, LLC
view allAdverse events under product code ODP
product code ODP- Injury
- 310
- Total
- 310
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 K173535
K-number listed on FDA's recall record- Z-0085-2022 — Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
- Z-0086-2022 — Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173535.
Data sourced from openFDA. This site is unofficial and independent of the FDA.