G7 Provisional Head Type 1 Half Tray Kit

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: G7 PROVISIONAL HEAD TYPE 1 HALF TRAY KIT FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Model / Reference: 110010946 FDA UDI

Identifiers

Catalog Number: 110010946 FDA UDI
Primary DI / UDI-DI: 00880304569355 FDA UDI
510(k) Number: K121874 FDA UDI
FDA Product Code: LZO FDA UDI
PBI FDA UDI
OQI FDA UDI
OQG FDA UDI
KWZ FDA UDI
JDI FDA UDI
LPH FDA UDI
OQH FDA UDI
GMDN Term: Joint prosthesis implantation kit, reusable FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Joint prosthesis implantation kit, reusable

G7 Provisional Head Type 1 Half Tray Kit by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint prosthesis implantation kit, reusable.

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PROPHECY — MicroPort Orthopedics Inc. · Class II
Cadence Total Ankle System — Smith & Nephew, Inc. · Class I
IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
Evolution — MicroPort Orthopedics Inc. · Class II
GUARDIAN® — MicroPort Orthopedics Inc. · Class I
ADVANCE® — MicroPort Orthopedics Inc. · Class I
PROPHECY — MicroPort Orthopedics Inc. · Class II

Cleared under the same submission

K121874 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 68232358-817a-4726-8fe1-e95a13d70093 36 fields · synced May 30, 2026