FDA.report

CD Horizon™ ModuLeX™ Spinal System

Primary DI
00763000586003
Brand
CD Horizon™ ModuLeX™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
RBT019220
Device description
HANDLE RBT019220 RG SCALPEL 10.5
Published
2023-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications

CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K231184000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231184000CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2023-05-26OLO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000586003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000586003007630005860037630005860030763000586003

GMDN Terms

TermDefinition
Scalpel, reusableA hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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