VIRAGE OCT SPINAL FIXATION SYSTEM— 510(k) K133556
Substantially EquivalentZimmer Spine, Inc.
FDA 510(k) clearance K133556 for VIRAGE OCT SPINAL FIXATION SYSTEM, Substantially Equivalent on 2014-06-02. Applicant: Zimmer Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer Spine, Inc.
- Product code
- Code KWP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code KWP
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
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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 →
Recalls naming K133556
K-number listed on FDA's recall record- Z-1019-2016 — Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
- Z-0625-2016 — Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133556.
Data sourced from openFDA. This site is unofficial and independent of the FDA.