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4cis Vertu Spine System

FDA UDI

Class II (US FDA UDI)

by Solco Biomedical Company India Private Limited

Identity

Trade Name
4CIS VERTU SPINE SYSTEM FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Poly-axial Reduction Pedicle Screw, Ø mm : 7.5, Length mm: 70 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System FDA UDI
Model / Reference
AISP-1036-7570 FDA UDI
Description
Poly-axial Reduction Pedicle Screw, Ø mm : 7.5, Length mm: 70 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System FDA UDI

Identifiers

Catalog Number
1036-7570 FDA UDI
Primary DI / UDI-DI
00840185305718 FDA UDI
510(k) Number
K202498 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

4cis Vertu Spine System by Solco Biomedical Company India Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Cleared under the same submission

K202498 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Solco Biomedical Company India Private Limited

Sources (1)

  • FDA UDI db55c726-3fc3-4242-ba83-be2cb4180720 35 fields · synced May 31, 2026