openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-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.
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
These labels are deterministic app interpretations, not FDA categories.
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
Code information
GTIN 00191375013006, Lot Number TM0126527
Distribution pattern
US Nationwide distribution.
device · product 2 of 2
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.
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
These labels are deterministic app interpretations, not FDA categories.
The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
