OsteoMed

FDA UDI

Class II (US FDA UDI)

by Osteomed Corp.

Identity

Trade Name: OsteoMed FDA UDI
Generic Name: Implantable craniofacial bone distractor FDA UDI
Device Name: SpectrumTM Short Left Maxillary Plate Assembly FDA UDI
Model / Reference: 217-0071 FDA UDI
Description: SpectrumTM Short Left Maxillary Plate Assembly FDA UDI

Identifiers

Catalog Number: 217-0071 FDA UDI
Primary DI / UDI-DI: 00845694004671 FDA UDI
FDA Product Code: MQN FDA UDI
GMDN Term: Implantable craniofacial bone distractor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4760 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

Category: Implantable craniofacial bone distractor

OsteoMed by Osteomed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable craniofacial bone distractor.

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DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II
DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC · Class II
DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II
DISTRACTION, EXTERNAL — KLS-Martin L.P. · Class II
DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II

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: Osteomed Corp.

Sources (1)

FDA UDI 6d41da69-4fda-410d-8f16-0870a73e5af1 36 fields · synced May 29, 2026