FDA.reportPublic FDA data

Total Foot System 2

Primary DI
00885556838228
Brand
Total Foot System 2
Company
Smith & Nephew, Inc.
Model
2805016
Catalog number
2805016
Device description
MPJ FUSION PLATE MEDIUM LEFT
Published
2023-04-18
Public version status
Update
Distribution status
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
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100502000
K123000000
K210016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100502000ASCENSION TOTAL PLATE SYSTEMAscension Orthopedics, Inc.2010-08-02HRS
K123000000INTEGRA TOTAL FOOT SYSTEMSIntegra LifeSciences Corporation2012-12-21HRS
K210016000Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS SystemIntegra LifeSciences Corporation2021-07-27HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556838228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556838228008855568382288855568382280885556838228

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00: -

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053782783830TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783847TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783915TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783922TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783939TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783946TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783953TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783960TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783977TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784134TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784141TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784158TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784165TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784172TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784189TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784264CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784271CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784288CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784295CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784301CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784318CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784325CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784523CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784530CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784547CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784554CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784561CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784578CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784585CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784592CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19