← Back to catalogue

ORTHROS Posterior Stabilization System

FDA UDI

Class II (US FDA UDI)

by Camber Spine Technologies

Identity

Trade Name
ORTHROS Posterior Stabilization System FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Ø6.5mm Polyaxial Pedicle Screw, 65mm Lg. FDA UDI
Model / Reference
CP-004-21 FDA UDI
Description
Ø6.5mm Polyaxial Pedicle Screw, 65mm Lg. FDA UDI

Identifiers

Primary DI / UDI-DI
B030CP004021 FDA UDI
510(k) Number
K133366 FDA UDI
FDA Product Code
KWQ FDA UDI
MNH FDA UDI
MNI FDA UDI
NKB FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
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 Posterior Stabilization System by Camber Spine Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K133366 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Camber Spine Technologies

Sources (1)

  • FDA UDI 47d5f874-76a2-450a-8ccf-f878ac51c0c9 36 fields · synced May 30, 2026