Pro-fix™ Precision Fixation System

FDA UDI

Class II (US FDA UDI)

by Osteogenics Biomedical, Inc.

Identity

Trade Name: Pro-fix™ Precision Fixation System FDA UDI
Generic Name: Craniofacial bone screw, non-bioabsorbable FDA UDI
Device Name: 1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screw FDA UDI
Model / Reference: PFB14-5 FDA UDI
Description: 1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screw FDA UDI

Identifiers

Primary DI / UDI-DI: D765PFB1451 FDA UDI
510(k) Number: K093719 FDA UDI
FDA Product Code: DZL FDA UDI
GMDN Term: Craniofacial bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 14.0 Millimeter FDA UDI

Category: Craniofacial bone screw, non-bioabsorbable

Pro-fix™ Precision Fixation System by Osteogenics Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Craniofacial bone screw, non-bioabsorbable.

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MatrixMANDIBLE — Synthes · Class II
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Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · Class II

Cleared under the same submission

K093719 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: Osteogenics Biomedical, Inc.

Sources (1)

FDA UDI b137dbe6-86d8-4b22-a489-5e275f4cd73f 35 fields · synced May 30, 2026