ZESPIN SI Joint Fusion System— 510(k) K223521
Substantially EquivalentAegis Spine, Inc.
FDA 510(k) clearance K223521 for ZESPIN SI Joint Fusion System, Substantially Equivalent on 2023-01-20. Applicant: Aegis Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Aegis Spine, Inc.
- 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
- Englewood, CO, US
Recent devices under product code OUR
view allMore clearances from Aegis Spine, Inc.
view all- 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
- K203531 — XYPAN Expandable Lumbar Cage System
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.