Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head

FDA UDI

Class II (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name: Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head FDA UDI
Generic Name: Femoral head/stem prosthesis adaptor FDA UDI
Device Name: Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head, +10.5mm head length FDA UDI
Model / Reference: 3301.00.105 FDA UDI
Description: Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head, +10.5mm head length FDA UDI

Identifiers

Primary DI / UDI-DI: 00814703017483 FDA UDI
510(k) Number: K213580 FDA UDI
FDA Product Code: LZO FDA UDI
LPH FDA UDI
MBL FDA UDI
GMDN Term: Femoral head/stem prosthesis adaptor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Length — +10.5 Millimeter FDA UDI

Category: Femoral head/stem prosthesis adaptor

Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Femoral head/stem prosthesis adaptor.

PROFEMUR® — MicroPort Orthopedics Inc. · Class II
Fusion Taper Sleeve +6mm — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Biolox — Howmedica Osteonics Corp. · Class II
BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Solitude Unipolar — ORTHO DEVELOPMENT CORP. · Class II
CONSERVE® — MicroPort Orthopedics Inc. · Class II
PROFEMUR® — MicroPort Orthopedics Inc. · Class II

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: Total Joint Orthopedics, Inc.

Sources (1)

FDA UDI 635de555-f1fa-4b99-bae0-2374de9066a8 37 fields · synced May 30, 2026