SPIRA Open Matrix LLIF— 510(k) K180724
Substantially EquivalentCamber Spine Technologies, LLC
FDA 510(k) clearance K180724 for SPIRA Open Matrix LLIF, Substantially Equivalent on 2018-06-25. Applicant: Camber Spine Technologies, LLC. Device class: 2.
Clearance details
- Applicant
- Camber Spine Technologies, 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
- Wayne, PA, US
Recent devices under product code MAX
view allMore clearances from Camber Spine Technologies, LLC
view all- K232256 — Alcantara Thoracolumbar Plate System
- K203503 — Camber Sacroiliac (SI) Fixation 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
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.