FDA.reportPublic FDA data

DYNAMIC COMPRESSION SMA Staple System

Primary DI
00885074423890
Brand
DYNAMIC COMPRESSION SMA Staple System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
8164605
Device description
5MM X 10MM SMA 4-PRONG STAPLE
Published
2015-09-17
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
00885074423890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885074423890008850744238908850744238900885074423890

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter
Outer Diameter5Millimeter

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
Primary DIBrandCompanyProduct codePublished
00815432028108DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2022-10-24
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
00815432028177DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20