Camber Sacroiliac (SI) Fixation System— 510(k) K203503
Substantially EquivalentCamber Spine Technologies, LLC
FDA 510(k) clearance K203503 for Camber Sacroiliac (SI) Fixation System, Substantially Equivalent on 2022-09-02. Applicant: Camber Spine Technologies, LLC. Device class: 2.
Clearance details
- Applicant
- Camber Spine Technologies, LLC
- Product code
- Code OUR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- King Of Prussia, PA, US
Recent devices under product code OUR
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view all- K232256 — Alcantara Thoracolumbar Plate System
- K210595 — SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
- K191584 — FORTICO Anterior Cervical Fixation System
- K180980 — ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System
- K180724 — SPIRA Open Matrix LLIF
Adverse events under product code OUR
product code OUR- Death
- 3
- Injury
- 347
- Total
- 350
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.