ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System— 510(k) K221050

Name: FDA 510(k) clearance K221050
Creator: U.S. Food and Drug Administration
Published: 2022-06-30

Substantially Equivalent

Aegis Spine, Inc.

FDA 510(k) clearance K221050 for ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System, Substantially Equivalent on 2022-06-30. 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: 2022-04-11
Decision date: 2022-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

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K261381 — TiLink-L SI Joint Fusion System2026-08-24
K260477 — CATAMARAN SI Joint Fusion System2026-04-08
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

More clearances from Aegis Spine, Inc.

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K223521 — ZESPIN SI Joint Fusion System2023-01-20
K223719 — Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System2023-01-11
K221719 — ABTross ALIF Expandable Cage System2022-11-03
K203531 — XYPAN Expandable Lumbar Cage System2021-01-29

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.