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P.l.u.s.®

FDA UDI

Class II (US FDA UDI)

by Spine Vision, Inc.

Identity

Trade Name
P.L.U.S.® FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
ST Lateral Connector FDA UDI
Model / Reference
U1-L400 FDA UDI
Description
ST Lateral Connector FDA UDI

Identifiers

Primary DI / UDI-DI
03663136015200 FDA UDI
510(k) Number
K032398 FDA UDI
FDA Product Code
KWQ FDA UDI
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector 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

Yes

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 connector

P.l.u.s.® by Spine Vision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K032398 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spine Vision, Inc.

Sources (1)

  • FDA UDI e8a29889-28e9-4588-bc68-12c01d7c2373 35 fields · synced Jun 1, 2026