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Orthros Mis

FDA UDI

Class II (US FDA UDI)

by Camber Spine Technologies

Identity

Trade Name
ORTHROS MIS FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Ø7.5mm MIS Orthros Dual Thread MIS Screw, 65mm, Long Tower FDA UDI
Model / Reference
ORM-1-7560L FDA UDI
Description
Ø7.5mm MIS Orthros Dual Thread MIS Screw, 65mm, Long Tower FDA UDI

Identifiers

Catalog Number
NA FDA UDI
Primary DI / UDI-DI
B030ORM17565L0 FDA UDI
510(k) Number
K180980 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

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

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

Cleared under the same submission

K180980 also covers:

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 79d0497d-bab2-49cf-ac66-608edfb5a061 37 fields · synced May 31, 2026