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Klassic BiPolar Trial

FDA UDI

Class I (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name
Klassic BiPolar Trial FDA UDI
Generic Name
Bipolar femoral head outer component, hemiarthroplasty FDA UDI
Device Name
BiPolar Trial, 55mm OD, 28mm Head FDA UDI
Model / Reference
1322.55.028 FDA UDI
Description
BiPolar Trial, 55mm OD, 28mm Head FDA UDI

Identifiers

Primary DI / UDI-DI
00819251021524 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Bipolar femoral head outer component, hemiarthroplasty 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

Yes

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

No

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: Bipolar femoral head outer component, hemiarthroplasty

Klassic BiPolar Trial by Total Joint Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bipolar femoral head outer component, hemiarthroplasty.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Total Joint Orthopedics, Inc.

Sources (1)

  • FDA UDI 433d0fce-bb92-4c59-9305-64a1645813ad 36 fields · synced May 31, 2026