← Back to catalogue

Made-To-Order

FDA UDI

Class I (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
Made-To-Order FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
Inbone® Poly Insertion Tool FDA UDI
Model / Reference
SMS00488 FDA UDI
Description
Inbone® Poly Insertion Tool FDA UDI

Identifiers

Catalog Number
SMS00488 FDA UDI
Primary DI / UDI-DI
00889797108102 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable 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

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

Yes

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

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Made-To-Order by Wright Medical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Wright Medical Technology, Inc.

Sources (1)

  • FDA UDI 2c3070d3-c565-48eb-be29-31f1e8e419b9 36 fields · synced Jun 8, 2026