FDA.reportPublic FDA data

Medtronic

Primary DI
00860012987863
Brand
Medtronic
Company
Quantum Ops, Inc.
Model
Anatomic Access Arm
Catalog number
81800030
Device description
This device aims to improve surgical efficiency and precision of various spine surgeries by providing a reliable and versatile mechanism for holding retractors.
Published
2025-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BWNTable And Attachments, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012987863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012987863008600129878638600129878630860012987863

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036253884
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012987870MedtronicAnatomic Access Quick Connect Adapter818000332025-12-19
00860014655944MedtronicSterile Pack A³ Drape PK 1818000312025-12-19
00860012987818Adaptable Adaptable Rail Extender 804-33-0062025-06-02
00860012987825StrykerPivot Screw3105-400-0362025-02-12
00860012987801Arvis Arvis C Tracker Mount 804-33-0052024-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842180148864ELMED INCORPORATEDELMED INCORPORATEDBWN2026-06-08
00724995232030NASTERIS CORPORATIONBWN2026-05-26
10381780542254MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
10381780542261MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
03701602300044ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300051ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300068ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300075ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300099Velcro Strap longInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300105PURIST - Leg positioning systemInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300112PURIST / OLH - Boot S - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300129PURIST / OLH - Boot M - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300136OLH #ERDP - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300143OLH #ERD - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300150OLH #ER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300167OLH #BHA- BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300174OLH #ED - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300181OLH - DENYER PLUS - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300198OLH - DENYER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300204OLH - US/EU - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300211POP UNIVERSALInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300228OLH #ERDPInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300235OLH #ERDInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300242OLH #ERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300259MP XRAYCERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300266DAA TOP 360Innovative Orthopedic Technologies AGBWN2026-01-13
03701602300273OLH #BHAInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300280OLH #BHSInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300297OLH #EDInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300303OLH - DENYER PLUSInnovative Orthopedic Technologies AGBWN2026-01-13