Px®

FDA UDI

Class I (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name: Px® FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: SST FDA UDI
Model / Reference: LS-265-11 FDA UDI
Description: SST FDA UDI

Identifiers

Catalog Number: LS-265-11 FDA UDI
Primary DI / UDI-DI: M711LS265110 FDA UDI
510(k) Number: K150500 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 11 Millimeter FDA UDI
Width — 12 Millimeter FDA UDI

Category: Spinal implant trial

Px® by Innovasis, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Novel — ALPHATEC SPINE, INC. · Class II
Scarlet AL-T Instruments — Spineart · Class II
IdentiTi — ALPHATEC SPINE, INC. · Class II
Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC. · Class II
IdentiTi — ALPHATEC SPINE, INC. · Class II
MLX — Nuvasive, Inc. · Class I
IdentiTi — ALPHATEC SPINE, INC. · Class II
ROI-A — Ldr Spine USA · Class II

Cleared under the same submission

K150500 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Innovasis, Inc.

Sources (1)

FDA UDI 50978f96-2b21-4662-9128-d8b41cf43435 37 fields · synced May 31, 2026