FDA.reportPublic FDA data

DYNAMIC COMPRESSION SMA Staple System

Primary DI
00721902671838
Brand
DYNAMIC COMPRESSION SMA Staple System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
8162110
Device description
STAPLE 8162110 10MM X 13MM 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
00721902671838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902671838007219026718387219026718380721902671838

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
Device Size Text, specify0

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000674397MSB Reusable Instruments98700052026-10-23
00763000749903CD HORIZON® Fenestrated Screw Spinal System557510245302026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal System557510275502026-10-23
00763000777500MSB CD HORIZON Spinal System557500465352026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal System557500475452026-10-23
00763000777623MSB CD HORIZON Spinal System557500475502026-10-25
00763000786434MSB CD HORIZON Spinal System65305302026-10-25
00763000857783T2 STRATOSPHERE™ Expandable Corpectomy System436125C2026-10-25
00763000874360MSB SHILLA Growth Guidance System76704312026-10-23
00763000880118MSB Reusable Instruments79670112026-10-23
00199150076451Medtronic Reusable InstrumentsX36902502026-10-19
00199150080373Medtronic Reusable InstrumentsX02260452026-10-19
00199150080380Medtronic Reusable InstrumentsX02260462026-10-19
00199150080397Medtronic Reusable InstrumentsX02260472026-10-19
00199150080403Medtronic Reusable InstrumentsX02260502026-10-19
00824846003922Medtronic Reusable InstrumentsEX06260022026-10-19
00824846013082Medtronic Reusable InstrumentsX09074302026-10-19
00824846013600Medtronic Reusable InstrumentsX07260042026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal System557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal System557510255302026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00815432026241HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
00815432026258HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
B56217634WB0Memory StapleWishbone Medical, Inc.JDR2020-08-06
00815432027255DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-06-03
00815432026111DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026128DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026135HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026142HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026180HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026197HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026203HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026326DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026340HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432028788MotoBAND™ CP DynaForce®CROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432028726MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028795MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028801MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028818MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028184DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-03-31
00815432028221DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-03-31
00815432027279DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432027286DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028115DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028122DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028139DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028146DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028153DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028160DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
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