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1.5mm System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
1.5MM SYSTEM FDA UDI
Generic Name
Cranioplasty plate screw FDA UDI
Model / Reference
95-6105X FDA UDI

Identifiers

Catalog Number
95-6105X FDA UDI
Primary DI / UDI-DI
00888233001595 FDA UDI
510(k) Number
K121624 FDA UDI
K953385 FDA UDI
FDA Product Code
GWO FDA UDI
JEY FDA UDI
HBW FDA UDI
GXR FDA UDI
GMDN Term
Cranioplasty plate screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5320 FDA UDI
872.4760 FDA UDI
882.5360 FDA UDI
882.5250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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: Cranioplasty plate screw

1.5mm System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate screw.

Cleared under the same submission

K121624 also covers:

K953385 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Microfixation, Inc

Sources (1)

  • FDA UDI 60979ac7-46ba-49ab-bf28-866fd9cbb84c 35 fields · synced May 30, 2026