ASTRA-OCT Spine System

FDA UDI

Class II (US FDA UDI)

by Spinecraft Llc

Identity

Trade Name: ASTRA-OCT Spine System FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: ASTRA-OCT Dia.3.5mm CoCr Occipital Rod, 300mm x 60Deg (120Deg) FDA UDI
Model / Reference: A3OR-35-6030K FDA UDI
Description: ASTRA-OCT Dia.3.5mm CoCr Occipital Rod, 300mm x 60Deg (120Deg) FDA UDI

Identifiers

Catalog Number: A3OR-35-6030K FDA UDI
Primary DI / UDI-DI: 00193082109690 FDA UDI
510(k) Number: K181350 FDA UDI
FDA Product Code: KWP FDA UDI
NKG FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3075 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System by Spinecraft Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system rod.

The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · 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

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

Manufacturer

Manufacturer: Spinecraft Llc

Sources (1)

FDA UDI e877129f-10ca-42d7-a9fd-a08508aa9753 36 fields · synced May 30, 2026