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: Spinal bone set screw FDA UDI
Device Name: ASTRA-OCT T15 Set Screw, Flat FDA UDI
Model / Reference: A3S-T15F FDA UDI
Description: ASTRA-OCT T15 Set Screw, Flat FDA UDI

Identifiers

Catalog Number: A3S-T15F FDA UDI
Primary DI / UDI-DI: 00193082110436 FDA UDI
510(k) Number: K181350 FDA UDI
FDA Product Code: NKG FDA UDI
KWP FDA UDI
GMDN Term: Spinal bone set screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3075 FDA UDI
888.3050 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: Spinal bone set screw

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

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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

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Manufacturer

Manufacturer: Spinecraft Llc

Sources (1)

FDA UDI 0486bc05-c1a4-4cdf-925e-0a0868ada5ed 36 fields · synced May 30, 2026