Bone Fixation Cerclage, Sublaminar

OWI · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3010

Classification

FDA Product Code: OWI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3010
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

Market data

Cleared 510(k) submissions: 36
Registered establishments: 66

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown