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Implanet Spine System

FDA UDI

Class II (US FDA UDI)

by Implanet

Identity

Trade Name
IMPLANET SPINE SYSTEM FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
Straight Union Rod CoCr FDA UDI
Model / Reference
Straight Union Rod CoCr FDA UDI
Description
Straight Union Rod CoCr FDA UDI

Identifiers

Catalog Number
350369 FDA UDI
Primary DI / UDI-DI
03607503503693 FDA UDI
510(k) Number
K143731 FDA UDI
FDA Product Code
OSH FDA UDI
MNH FDA UDI
KWP FDA UDI
NKB FDA UDI
MNI FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 600 Millimeter FDA UDI
Outer Diameter — 4.5 Millimeter FDA UDI

Category: Trans-facet-screw internal spinal fixation system, sterile

Implanet's Straight Union Rod CoCr is a sterile, trans-facet spinal fixation system designed for the treatment of various spinal conditions. This implantable device consists of rods, plates, and facet fixation screws that are inserted bilaterally through the facet joint to stabilize and fuse vertebrae.

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

Cleared under the same submission

K143731 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Implanet

Sources (1)

  • FDA UDI 5450a918-ccdf-42ce-9e6a-e8e6d29ea4ab 36 fields · synced Jul 24, 2026