FDA.reportPublic FDA data

NA

Primary DI
10886982118950
Brand
NA
Company
Synthes GmbH
Model
04.211.010
Catalog number
04211010
Device description
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 10MM
Published
2015-09-14
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
K100776000
K103243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100776000SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEMSynthes (Usa)2010-08-03HRS
K1032430002.4MM VA-LCP INTERCARPAL FUSION SYSTEMSynthes (Usa)2011-01-21HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982118950PrimaryGS10
H679042110100SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698211895010886982118950

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14
10886982077899NA03.311.013033110132015-09-14
10886982078131NA03.311.058033110582015-09-14
10886982078148NA03.311.059033110592015-09-14
10886982078155NA03.311.060033110602015-09-14
10886982078186NA03.311.062033110622015-09-14
10886982078193NA03.311.070033110702015-09-14
10886982078209NA03.311.071033110712015-09-14
10886982078247NA03.311.090033110902015-09-14
10886982078254NA03.311.091033110912015-09-14
10886982078261NA03.311.092033110922015-09-14
10886982078438NA03.311.201033112012015-09-14
10886982078445NA03.311.202033112022015-09-14
10886982078452NA03.311.203033112032015-09-14
10886982078469NA03.311.204033112042015-09-14
10886982078476NA03.311.205033112052015-09-14
10886982078520NA03.311.220033112202015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190446944348Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952213Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952220Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952237Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952244Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952251Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952268Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952275Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952282Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952299Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952305Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952312Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00190446952329Arsenal FootTrilliant Surgical, LLCHRS2026-06-25
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25