The JASPER Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by GBS Commonwealth Co., Ltd.

Identity

Trade Name: The JASPER Spinal Fixation System FDA UDI
Generic Name: Bone-screw internal spinal fixation system, non-sterile FDA UDI
Model / Reference: L11H-7570 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800057243571 FDA UDI
510(k) Number: K190762 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

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

The JASPER Spinal Fixation System is a non-sterile, external spinal fixation device used in orthopedic treatment for various spinal instabilities or deformities. It consists of a combination of anchors, interconnection mechanisms, longitudinal members, and/or transverse connectors, making it an ideal solution for implantable devices. With its robust design and adjustable features, the JASPER system provides optimal support and stability to patients undergoing spinal surgery.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: GBS Commonwealth Co., Ltd.

Sources (1)

FDA UDI deedab25-5579-4449-a518-3a3681f504ce 33 fields · synced Jul 30, 2026

The JASPER Spinal Fixation System

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)