FDA.reportPublic FDA data

DYNAMIC COMPRESSION SMA Staple System

Primary DI
00721902662645
Brand
DYNAMIC COMPRESSION SMA Staple System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
8162104
Device description
STAPLE 8162104 4MM X 10MM 2PRONG SMA
Published
2015-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRSTAPLE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012081000DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEMMedtronic Sofamor Danek, Inc.2001-10-01JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721902662645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902662645007219026626457219026626450721902662645

GMDN Terms#

Term, Definition table
TermDefinition
Bone stapleA length of wire, typically curved or U-shaped, implanted into fractured bone to achieve fixation and repair. The device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). This device is not adjustable after it has been applied and is usually made of metal alloy material.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

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