ENDOSKELETON(R) TL INTERBODY FUSION DEVICE— 510(k) K140055
Substantially EquivalentTitan Spine, LLC
FDA 510(k) clearance K140055 for ENDOSKELETON(R) TL INTERBODY FUSION DEVICE, Substantially Equivalent on 2014-07-02. 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
- Traditional
- Location
- Bartlett, TN, 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.