BonOs® Inject Bone Cement; NEO Pedicle Screw System— 510(k) K222256
Substantially EquivalentNeo Medical SA
FDA 510(k) clearance K222256 for BonOs® Inject Bone Cement; NEO Pedicle Screw System, Substantially Equivalent on 2022-08-26. Applicant: Neo Medical SA. Device class: 2.
Clearance details
- Applicant
- Neo Medical SA
- Product code
- Code PML
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Villette (Lavaux), CH
Recent devices under product code PML
view all- K260286 — Dynamo Spinal Cement; Salvo® Spine System
- K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
- K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement +1 more
- K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement
More clearances from Neo Medical SA
view allAdverse events under product code PML
product code PML- Death
- 8
- Total
- 8
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.