FDA.reportPublic FDA data

KONG-TL VBR System, Trial Implant, XS, Ø 19 mm x 22 mm

Primary DI
07640172551011
Brand
KONG-TL VBR System, Trial Implant, XS, Ø 19 mm x 22 mm
Company
icotec AG
Model
44-005-22
Catalog number
44-005-22
Device description
KONG-TL VBR System, Trial Implant, XS, Ø 19 mm x 22 mm
Published
2020-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal Vertebral Body Replacement Device
PLRSpinal Vertebral Body Replacement Device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640172551011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640172551011076401725510117640172551011

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
480789465
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640164847870KONG-TL VBR System, KONG-TL VBR E, Container, completeicotec AGPLR2023-09-08
07640172550076KONG-C VBR System, KONG-C VBR M, Container, completeicotec AGPLR2023-09-08
07640164847405KONG-TL VBR E, Expandable Body, Standalone, XXS, Ø 19 mm x 19 - 23 mmicotec AGPLR2020-06-19
07640164847412KONG-TL VBR E, Expandable Body, Standalone, XS, Ø 19 mm x 22 - 29 mmicotec AGPLR2020-06-19
07640164847429KONG-TL VBR E, Expandable Body, S, Ø 19 mm x 20 - 24 mmicotec AGPLR2020-06-19
07640164847436KONG-TL VBR E, Expandable Body, M, Ø 19 mm x 23 - 30 mmicotec AGPLR2020-06-19
07640164847443KONG-TL VBR E, Expandable Body, L, Ø 19 mm x 27 - 37 mmicotec AGPLR2020-06-19
07640164847450KONG-TL VBR E, Expandable Body, XL, Ø 19 mm x 33 - 49 mmicotec AGPLR2020-06-19
07640164847467KONG-TL VBR, Extension, S and Screw, Ø 19 mm x 20 mmicotec AGPLR2020-06-19
07640164847474KONG-TL VBR, Extension, M and Screw, Ø 19 mm x 35 mmicotec AGPLR2020-06-19
07640164847481KONG-TL VBR, Screw, M8 x 6.0 mmicotec AGPLR2020-06-19
07640164847498KONG-TL VBR, End Plate, round, S and Screw, 0° x 26 mmicotec AGPLR2020-06-19
07640164847504KONG-TL VBR, End Plate, round, M and Screw, 0° x 33 mmicotec AGPLR2020-06-19
07640164847511KONG-TL VBR, End Plate, round, L and Screw, 0° x 43 mmicotec AGPLR2020-06-19
07640164847528KONG-TL VBR, End Plate, round, S and Screw, 4° x 26 mmicotec AGPLR2020-06-19
07640164847535KONG-TL VBR, End Plate, round, M and Screw, 4° x 33 mmicotec AGPLR2020-06-19
07640164847542KONG-TL VBR, End Plate, round, L and Screw, 4° x 43 mmicotec AGPLR2020-06-19
07640164847559KONG-TL VBR, End Plate, round, S and Screw, 8° x 26 mmicotec AGPLR2020-06-19
07640164847566KONG-TL VBR, End Plate, round, M and Screw, 8° x 33 mmicotec AGPLR2020-06-19
07640164847573KONG-TL VBR, End Plate, round, L and Screw, 8° x 43 mmicotec AGPLR2020-06-19
07640164847580KONG-TL VBR, End Plate, round, S and Screw, 12° x 26 mmicotec AGPLR2020-06-19
07640164847597KONG-TL VBR, End Plate, round, M and Screw, 12° x 33 mmicotec AGPLR2020-06-19
07640164847603KONG-TL VBR, End Plate, round, L and Screw, 12° x 43 mmicotec AGPLR2020-06-19
07640164847610KONG-TL VBR, End Plate, rectangular, M and Screw, 0° x 33 mmicotec AGPLR2020-06-19
07640164847627KONG-TL VBR, End Plate, rectangular, L and Screw, 0° x 43 mmicotec AGPLR2020-06-19
07640164847634KONG-TL VBR, End Plate, rectangular, XL and Screw, 0° x 52 mmicotec AGPLR2020-06-19
07640164847641KONG-TL VBR, End Plate, rectangular, M and Screw, 4° x 33 mmicotec AGPLR2020-06-19
07640164847658KONG-TL VBR, End Plate, rectangular, L and Screw, 4° x 43 mmicotec AGPLR2020-06-19
07640164847665KONG-TL VBR, End Plate, rectangular, XL and Screw, 4° x 52 mmicotec AGPLR2020-06-19
07640164847672KONG-TL VBR, End Plate, rectangular, M and Screw, 8° x 33 mmicotec AGPLR2020-06-19