Simplex

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: Simplex FDA UDI
Generic Name: Orthopaedic cement, non-antimicrobial FDA UDI
Device Name: Half Dose Bone Cement, 10 pack catalog number is 6188-1-010 FDA UDI
Model / Reference: 6188-1-001 FDA UDI
Description: Half Dose Bone Cement, 10 pack catalog number is 6188-1-010 FDA UDI

Identifiers

Catalog Number: 6188-1-001 FDA UDI
Primary DI / UDI-DI: 07613327128437 FDA UDI
510(k) Number: K062553 FDA UDI
FDA Product Code: LOD FDA UDI
GMDN Term: Orthopaedic cement, non-antimicrobial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 10.0 Milliliter FDA UDI
Weight — 20.0 Gram FDA UDI

Category: Orthopaedic cement, non-antimicrobial

Simplex by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K062553 also covers:

Simplex — Howmedica Osteonics Corp.

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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 86e02820-f2ee-4bf9-808a-f5f187b6d6d9 37 fields · synced May 30, 2026