ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL— 510(k) K141953
Substantially EquivalentTitan Spine, LLC
FDA 510(k) clearance K141953 for ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL, Substantially Equivalent on 2014-10-27. 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 →
Recalls naming K141953
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-1440-2021 — Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141953.
Data sourced from openFDA. This site is unofficial and independent of the FDA.