TOSCA

Primary DI
04047844002537
Brand
TOSCA
Company
SIGNUS Medizintechnik GmbH
Model
Cervical plate, 2-level
Catalog number
D2-044
Device description
The TOSCA Anterior Cervical Plate System consits of various sizes of bone plates and screws that are either fixed angle or variable angle. The screws are used to secure the plates to the vertebral bodies of the cervical spine through the anterior approach. The plates and screws are made from Titanium alloy Ti6Al4V, are in conformance with ASTM F136, and are supplied non-sterile.
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043082000THE TOSCA ANTERIOR CERVICAL PLATE SYSTEMSignus Medizintechnik GmbH2004-11-23KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844002537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844002537040478440025374047844002537

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49602391660info@signus.com

Regulatory Flags#

DUNS number
344203948
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
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04047844005705KAINOS+Bone graft substitute, granules 2-3mmK006NT2015-09-24
04047844005712KAINOS+Bone graft substitute, insert for NUBICKNB0413142018-09-20
04047844005729KAINOS+Bone graft substitute, insert for NUBICKNB0513142018-09-20
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04047844005996KAINOS+Bone graft substitute, granules 1-2mmKS03NT2015-09-24
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