Signature

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: SIGNATURE FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Model / Reference: 42-100102 FDA UDI

Identifiers

Catalog Number: 42-100102 FDA UDI
Primary DI / UDI-DI: 00880304516304 FDA UDI
510(k) Number: K111863 FDA UDI
FDA Product Code: KWY FDA UDI
LZO FDA UDI
MAY FDA UDI
JDI FDA UDI
LPH FDA UDI
KWZ FDA UDI
MEH FDA UDI
GMDN Term: Orthopaedic implantation sleeve, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3390 FDA UDI
888.3353 FDA UDI
888.3350 FDA UDI
888.3358 FDA UDI
888.3310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

FDA UDI

Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implantation sleeve, reusable

Signature by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K111863 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 II	Pending data

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Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI f76c332d-38f1-4880-a2cd-6779148279ae 35 fields · synced Jun 8, 2026