Fixture ST 3mm

FDA UDI

Class II (US FDA UDI)

by Cochlear Bone Anchored Solutions AB

Identity

Trade Name: Fixture ST 3mm FDA UDI
Generic Name: Craniofacial bone screw, non-bioabsorbable FDA UDI
Device Name: Fixture ST 3mm FDA UDI
Model / Reference: 90438 FDA UDI
Description: Fixture ST 3mm FDA UDI

Identifiers

Catalog Number: 90438 FDA UDI
Primary DI / UDI-DI: 09321502014335 FDA UDI
510(k) Number: K945154 FDA UDI
FDA Product Code: FZE FDA UDI
GMDN Term: Craniofacial bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3680 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 3 Millimeter FDA UDI

Category: Craniofacial bone screw, non-bioabsorbable

Fixture ST 3mm by Cochlear Bone Anchored Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Craniofacial bone screw, non-bioabsorbable.

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MatrixMANDIBLE — Synthes · Class II
OsteoMed — Osteomed Corp. · Class II
LEVEL ONE NEURO, STERILE — KLS-Martin L.P. · Class II
Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · Class II

Cleared under the same submission

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: Cochlear Bone Anchored Solutions AB

Sources (1)

FDA UDI 8348dd29-5d8b-4a0d-9818-1cd3c5d79960 37 fields · synced May 30, 2026