K-number	K254061
Device name	Curiteva Porous PEEK Cervical Interbody Fusion System
Applicant	Curiteva, Inc.
Product code	ODP
Device class	Class II
Decision date	Jan 15, 2026
Decision	Substantially Equivalent
Regulation	888.3080

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Curiteva Porous PEEK Cervical Interbody Fusion System is a sterile implant designed for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or spinal instability causing radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device is used with supplemental fixation and bone graft materials to facilitate spinal fusion.

Technological characteristics

The implants are manufactured from implant-grade PEEK (ASTM F2026) with titanium alloy markers (ASTM F136). They feature a box-shaped design with an open central corridor for bone graft packing, a dense central ring, porous structure lining the graft corridor and superior/inferior surfaces, and a hydroxyapatite coating approximately 20nm thick.

Test standards cited

ASTM F2026 for implant-grade PEEK material and ASTM F136 for titanium alloy markers are cited as manufacturing standards.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Curiteva Porous PEEK Cervical Interbody Fusion System

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