Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL— 510(k) K142589
Substantially EquivalentTitan Spine, LLC
FDA 510(k) clearance K142589 for Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL, Substantially Equivalent on 2014-10-17. Applicant: Titan Spine, LLC. Device class: 2.
Clearance details
- Applicant
- Titan Spine, LLC
- Product code
- Code MAX
- 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 MAX
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
- K151596 — Endoskeleton TCS Interbody Fusion Device
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.