Nexframe Screws

FDA UDI

Class II (US FDA UDI)

by Fhc, Inc.

Identity

Trade Name: Nexframe Screws FDA UDI
Generic Name: Neurological stereotactic surgery system FDA UDI
Device Name: 1.6 x 10mm Cranial Bone Screws (3) FDA UDI
Model / Reference: SR-10-00804 FDA UDI
Description: 1.6 x 10mm Cranial Bone Screws (3) FDA UDI

Identifiers

Catalog Number: SR-10 FDA UDI
Primary DI / UDI-DI: 10873263008048 FDA UDI
510(k) Number: K012366 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Neurological stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Neurological stereotactic surgery system

Nexframe Screws by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K012366 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: Fhc, Inc.

Sources (1)

FDA UDI 67c3c6e0-01b9-4760-aa66-a5f716232a60 37 fields · synced Jun 8, 2026