← Back to catalogue

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 connector FDA UDI
Device Name
ASTRA-OCT Open Side-loading Angled Lateral Connector, 10mm FDA UDI
Model / Reference
A3L-OSA10 FDA UDI
Description
ASTRA-OCT Open Side-loading Angled Lateral Connector, 10mm FDA UDI

Identifiers

Catalog Number
A3L-OSA10 FDA UDI
Primary DI / UDI-DI
00193082110542 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 connector 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

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

Category: Bone-screw internal spinal fixation system connector

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 connector.

Cleared under the same submission

K181350 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
Spinecraft Llc

Sources (1)

  • FDA UDI 726c0c39-3569-4f2b-b9fd-7527a40d6ba9 36 fields · synced May 30, 2026