MODIFICATION TO DYNESYS SPINAL SYSTEM— 510(k) K043565
Substantially EquivalentZimmer Spine, Inc.
FDA 510(k) clearance K043565 for MODIFICATION TO DYNESYS SPINAL SYSTEM, Substantially Equivalent on 2005-03-11. Applicant: Zimmer Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer Spine, Inc.
- Product code
- Code NQP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code NQP
view allMore clearances from Zimmer Spine, Inc.
view all- K153631 — Zimmer Virage OCT Spinal Fixation System
- K150896 — Vitality Spinal Fixation System
- K151031 — Virage OCT Spinal Fixation System
- K142752 — Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
- K143626 — inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System
Recalls naming K043565
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043565.
Data sourced from openFDA. This site is unofficial and independent of the FDA.