XYPAN Expandable Lumbar Cage System— 510(k) K203531
Substantially EquivalentAegis Spine, Inc.
FDA 510(k) clearance K203531 for XYPAN Expandable Lumbar Cage System, Substantially Equivalent on 2021-01-29. Applicant: Aegis Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Aegis Spine, Inc.
- 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
- Englewood, CO, US
Recent devices under product code MAX
view allMore clearances from Aegis Spine, Inc.
view all- K223521 — ZESPIN SI Joint Fusion System
- K223719 — Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
- K221719 — ABTross ALIF Expandable Cage System
- K221050 — ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate 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.