FDA.reportPublic FDA data

Virage®

Primary DI
00889024328167
Brand
Virage®
Company
ZIMMER BIOMET INC
Model
07.01707.037
Catalog number
07.01707.037
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024328167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024328167008890243281678890243281670889024328167

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length39Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)774-6368zimmer.consumerrelations@zimmerbiomet.com
+1(866)774-6368zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
045576443
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888480511557Lineum®14-52505314-5250532020-07-07
00887868289163Virage® OCT07.01770.00107.01770.0012020-02-13
00887868289170Virage®07.01771.00207.01771.0022020-02-13
00887868289187Virage®07.01772.00207.01772.0022020-02-13
00887868289194Virage®07.01773.00207.01773.0022020-02-13
00887868289385Virage® OCT07.01803.00107.01803.0012020-02-13
00887868244728Vital™730M0011730M00112019-06-04
00887868244735Vital™730M0012730M00122019-06-04
03662663063081Vital Spinal Fixation System710M11562024-06-26
03662663063098Vital Spinal Fixation System710M12562024-06-26
03662663063104Vital Spinal Fixation System710M13562024-06-26
03662663063111Vital Spinal Fixation System710M14562024-06-26
03662663063128Vital Spinal Fixation System710M15562024-06-26
03662663063135Vital Spinal Fixation System710M17562024-06-26
00887868528774VItal Spinal Fixation System850M00302024-06-11
00887868528781VItal Spinal Fixation System850M00312024-06-11
00887868528798VItal Spinal Fixation System850M00322024-06-11
00887868528804VItal Spinal Fixation System850M00332024-06-11
00887868528811VItal Spinal Fixation System850M00342024-06-11
00887868528828VItal Spinal Fixation System850M00352024-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
00193982572983CREOGLOBUS MEDICAL, INC.KWP2026-06-10
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536162109neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGKWP2026-06-08
00887517656582ReLineNuvasive, Inc.KWP2026-04-15
00841732151024PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151031PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151048PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151055PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151062PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151079PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151086PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732151093PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2024-09-27
00841732149847TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732150621TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2023-09-15
00841732163546PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732163553PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14
00841732163560PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWP2023-09-14