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Px®

FDA UDI

Class II (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name
Px® FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
SST FDA UDI
Model / Reference
LS-263 FDA UDI
Description
SST FDA UDI

Identifiers

Primary DI / UDI-DI
M711LS2630 FDA UDI
510(k) Number
K150500 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

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

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Cleared under the same submission

K150500 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innovasis, Inc.

Sources (1)

  • FDA UDI b94fa6d0-9ab1-49fa-b6a4-3fede7883ee7 35 fields · synced May 31, 2026