FDA.reportPublic FDA data

NA

Primary DI
10886982157133
Brand
NA
Company
Synthes GmbH
Model
222.578
Catalog number
222578
Device description
5.0MM SCREW NUT
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
HTYPIN, FIXATION, SMOOTH
HWCScrew, fixation, bone
JDWPIN, FIXATION, THREADED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000066000SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEMSynthes (Usa)2000-03-15HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982157133PrimaryGS10
H6792225780SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698215713310886982157133

GMDN Terms#

Term, Definition table
TermDefinition
Implantable bone nutA small, implantable block threaded on its inside surface designed to be threaded outside a bone bolt or screw (not included) for secure fastening/stabilisation. It is not intended to be internally threaded to the bolt/screw (i.e., it is not a set screw). It is made of metallic or non-metallic materials. This is a single-use device.

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
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
10850070500125CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
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10850070500163CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
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10850070500200CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
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10850070500309CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500316CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500323CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500330CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500347CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500354CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22