ProMIS™ Fixation System

FDA UDI

Class II (US FDA UDI)

by Premia Spine Ltd

Identity

Trade Name: ProMIS™ Fixation System FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: Straight Rod Ø6.0x135mm Hex Edge The ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae. FDA UDI
Model / Reference: 87667 FDA UDI
Description: Straight Rod Ø6.0x135mm Hex Edge The ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae. FDA UDI

Identifiers

Primary DI / UDI-DI: 07290115933505 FDA UDI
510(k) Number: K150380 FDA UDI
K170061 FDA UDI
K231844 FDA UDI
FDA Product Code: NKB FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod 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

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Dimensions & Sizes

Size: Length — 135 Millimeter FDA UDI
Outer Diameter — 6 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system rod

ProMIS™ Fixation System by Premia Spine Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system rod.

The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II

Cleared under the same submission

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: Premia Spine Ltd

Sources (1)

FDA UDI 788736ee-5c53-4466-b1c8-63cc58be24cb 36 fields · synced Jun 1, 2026