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ASTRA Spine System

FDA UDI

Class I (US FDA UDI)

by Spinecraft Llc

Identity

Trade Name
ASTRA Spine System FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
ASTRA Supplementary Implants Case FDA UDI
Model / Reference
6300-715 FDA UDI
Description
ASTRA Supplementary Implants Case FDA UDI

Identifiers

Catalog Number
6300-715 FDA UDI
Primary DI / UDI-DI
00193082154539 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

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

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinecraft Llc

Sources (1)

  • FDA UDI 82a1a1b7-157b-4207-b8e8-e8965f7004f9 35 fields · synced Jun 8, 2026