STERN FIX Sternal Stabilization System— 510(k) K221795
Substantially EquivalentNeos Surgery S.L
FDA 510(k) clearance K221795 for STERN FIX Sternal Stabilization System, Substantially Equivalent on 2022-10-19. Applicant: Neos Surgery S.L. Device class: 2.
Clearance details
- Applicant
- Neos Surgery S.L
- Product code
- Code JDQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3010
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barcelona, ES
Recent devices under product code JDQ
view allMore clearances from Neos Surgery S.L
view all- K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
- K211613 — Stern Fix Sternal Stabilization System
- K160739 — Cranial COVER
- K132044 — CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
- K101235 — CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
Adverse events under product code JDQ
product code JDQ- Death
- 9
- Injury
- 330
- Total
- 339
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.