FDA.reportPublic FDA data

CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 12 mm

Primary DI
07640172552995
Brand
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 12 mm
Company
icotec AG
Model
16-4020-34012
Catalog number
16-4020-34012
Device description
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 12 mm
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKGPosterior Cervical Screw System
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640172552995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640172552995076401725529957640172552995

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41717570000info@icotec.ch

Regulatory Flags#

DUNS number
480789465
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640172554227VADER Pedicle System, Nut Screw, Ti16-57-4100016-57-410002026-04-30
07640172554234VADER Pedicle System, Cross-Link, Ti, 30/34 mm16-57-9303416-57-930342026-04-30
07640172554241VADER Pedicle System, Cross-Link, Ti, 33/42 mm16-57-9344216-57-934422026-04-30
07640172554258VADER Pedicle System, Cross-Link, Ti, 40/53 mm16-57-9405316-57-940532026-04-30
07640172554265VADER Pedicle System, Cross-Link, Ti, 50/70 mm16-57-9507016-57-950702026-04-30
07640172553824CMORE® System, Torque Wrench, AO-Coupling45-400H45-400H2025-11-24
07640172552872icotec Systems, Torque-Limiting Adapter, 3.5 Nm60-03560-0352025-03-05
07640172552889VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm42-59642-5962025-03-05
07640172552902VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm42-546-142-546-12024-11-22
07640172552919VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm42-542-142-542-12024-11-22
07640172552087VADER Pedicle System, K-wire, Ø 1.1 × 472 mm42-54142-5412023-01-13
07640172552094VADER Pedicle System, K-wire, Nitinol, Ø 1.1 × 472 mm42-54242-5422023-01-13
07640172552100VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 × 472 mm42-54642-5462023-01-13
07640164840871VADER Pedicle System, K-wire, Ø 1.6 x 150 mm42-54542-5452019-07-31
07640164846408VADER Pedicle System, K-wire, threaded, Ø 1.6 x 472 mm42-54442-5442019-07-31
07640172553916KONG-TL VBR System, Guiding Sleeve for Locking Screwdriver44-05144-0512026-01-29
07640172552544CMORE® System, Awl45-01045-0102025-11-24
07640172552551CMORE® System, Pedicle Probe, Straight45-02045-0202025-11-24
07640172552568CMORE® System, Drill Guide Sleeve45-03045-0302025-11-24
07640172552575CMORE® System, Drill Guide Stop45-030-145-030-12025-11-24

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Primary DI, Brand, Company table
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