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Polaris™ 5.5 Spinal System

FDA UDI

Class II (US FDA UDI)

by Biomet Spine Llc

Identity

Trade Name
POLARIS™ 5.5 SPINAL SYSTEM FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Model / Reference
14-578225R FDA UDI

Identifiers

Catalog Number
14-578225R FDA UDI
Primary DI / UDI-DI
00880304944398 FDA UDI
FDA Product Code
KWQ FDA UDI
NKB FDA UDI
KWP FDA UDI
MNH FDA UDI
MNI FDA UDI
OSH FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
888.3070 FDA UDI
888.3050 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Polaris™ 5.5 Spinal System by Biomet Spine Llc — 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Spine Llc

Sources (1)

  • FDA UDI 83fada27-e579-4130-bed4-3bcdfdac0c16 35 fields · synced Jun 8, 2026