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Pls

FDA UDI

Class II (US FDA UDI)

by Sintea Plustek, LLC

Identity

Trade Name
PLS FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Model / Reference
PLS-150T315 FDA UDI

Identifiers

Primary DI / UDI-DI
08033726405912 FDA UDI
510(k) Number
K081631 FDA UDI
K112611 FDA UDI
FDA Product Code
KWP FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

Pls by Sintea Plustek, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K081631 also covers:

K112611 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sintea Plustek, LLC

Sources (1)

  • FDA UDI a026539d-f699-4cf0-aadf-13a9ab10dd95 33 fields · synced May 30, 2026