FDA.report

Robotic Graft Delivery Instruments

Primary DI
00763000708566
Brand
Robotic Graft Delivery Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
RBT060002
Device description
PLUNGER RBT060002 ROBOTIC GRFT DEL TUBE
Published
2023-08-24
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
K230716000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230716000Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.2023-07-18OLO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000708566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000708566007630007085667630007085660763000708566

GMDN Terms

TermDefinition
Orthopaedic graft inserterA hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. 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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