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PSS System

FDA UDI

Class II (US FDA UDI)

by Precision Spine, Inc.

Identity

Trade Name
PSS System FDA UDI
Generic Name
CT mobile medical facility FDA UDI
Device Name
8.5mm x 40mm SureLOK Polyaxial Screw FDA UDI
Model / Reference
SLP8540 FDA UDI
Description
8.5mm x 40mm SureLOK Polyaxial Screw FDA UDI

Identifiers

Catalog Number
SLP8540 FDA UDI
Primary DI / UDI-DI
00840019913829 FDA UDI
510(k) Number
K092128 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
GMDN Term
CT mobile medical facility 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

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

No

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: CT mobile medical facility

PSS System by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K092128 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Spine, Inc.

Sources (1)

  • FDA UDI bc99f516-b6d6-415a-94fe-8e3d5b7024e3 35 fields · synced Jun 1, 2026