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Orthros Mis

FDA UDI

Class I (US FDA UDI)

by Camber Spine Technologies

Identity

Trade Name
ORTHROS MIS FDA UDI
Generic Name
Bone biopsy needle FDA UDI
Device Name
Bone Aspiration Needle, 8 Ga with Trocar, 150mm Lg. FDA UDI
Model / Reference
CM-123-02 FDA UDI
Description
Bone Aspiration Needle, 8 Ga with Trocar, 150mm Lg. FDA UDI

Identifiers

Primary DI / UDI-DI
B030CM123020 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Bone biopsy needle FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone biopsy needle

Orthros Mis by Camber Spine Technologies — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone biopsy needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Camber Spine Technologies

Sources (1)

  • FDA UDI d0d58d65-ef6c-4cb9-bdca-af5b6abfbe71 34 fields · synced Jun 8, 2026