BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

ASTRA-OCT Spine System

DI: M824A3ST151 · Model: A3S-T15 · SPINECRAFT, LLC

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Product Codes

2

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: ASTRA-OCT Spine System
Primary DI: M824A3ST151
Version / Model: A3S-T15
Catalog Number: A3S-T15
Company Name: SPINECRAFT, LLC
Labeler DUNS: 783908713
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-10-03
Public Version: 5
Public Version Date: 2025-07-14
Public Version Status: Update
Public Device Record Key: b2f80b9f-c4e8-4822-a362-310d9d82c818
Distribution End Date: 2024-09-01

Device Description

ASTRA-OCT T15 Set Screw

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: Yes
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: Yes
Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NKG	Orthosis, cervical pedicle screw spinal fixation	Orthopedic	888.3075	2
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65553	Spinal bone set screw	A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	00193082083174	GS1
Primary	M824A3ST151	HIBCC

Customer Contacts

Phone: +1(999)999-1112
Email: [email protected]
Phone: +1(630)920-7300
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K181350	000