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X-Pac

FDA UDI

Class II (US FDA UDI)

by Expanding Innovations, Inc.

Identity

Trade Name
X-PAC FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
Cage Insertion Tool HT FDA UDI
Model / Reference
EI2451 FDA UDI
Description
Cage Insertion Tool HT FDA UDI

Identifiers

Catalog Number
EI2451 FDA UDI
Primary DI / UDI-DI
00850001720175 FDA UDI
510(k) Number
K160856 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

Yes

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

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

X-Pac by Expanding Innovations, 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

K160856 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Expanding Innovations, Inc.

Sources (1)

  • FDA UDI 87991a5c-6f9a-4b59-a471-42860bd3269f 35 fields · synced May 30, 2026