Baha

FDA UDI

Class II (US FDA UDI)

by Cochlear Bone Anchored Solutions AB

Identity

Trade Name: Baha FDA UDI
Generic Name: Craniofacial bone screw, non-bioabsorbable FDA UDI
Device Name: Healing cap with plug Ø20mm FDA UDI
Model / Reference: 92137 FDA UDI
Description: Healing cap with plug Ø20mm FDA UDI

Identifiers

Catalog Number: 92137 FDA UDI
Primary DI / UDI-DI: 09321502019583 FDA UDI
510(k) Number: K100360 FDA UDI
FDA Product Code: LXB FDA UDI
GMDN Term: Craniofacial bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3302 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

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 20 Millimeter FDA UDI

Category: Craniofacial bone screw, non-bioabsorbable

Baha 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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OsteoMed — Osteomed Corp. · Class II
MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC. · Class II
LEVEL ONE CMF — KLS-Martin L.P. · Class II
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 4e3081fe-8495-4598-94e8-60cdc866e424 37 fields · synced May 30, 2026