FDA.reportPublic FDA data

KONG-C VBR, End Plate & Screw, 6° / 14 x 13 mm

Primary DI
07640172550540
Brand
KONG-C VBR, End Plate & Screw, 6° / 14 x 13 mm
Company
icotec AG
Model
12-80-601413
Catalog number
12-80-601413
Device description
KONG-C VBR, End Plate & Screw, 6° / 14 x 13 mm
Published
2020-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
07640172550540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640172550540076401725505407640172550540

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
480789465
Device count
1
DM exempt
true
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

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