FDA.reportPublic FDA data

NA

Primary DI
10886982064332
Brand
NA
Company
Synthes GmbH
Model
02.306.007
Catalog number
02306007
Device description
LONG CANNULATED NAIL FOR PELVIC C-CLAMP II
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
JECCOMPONENT, TRACTION, INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JECComponent, Traction, InvasiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071476000SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMPSynthes (Usa)2007-08-24JEC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982064332PrimaryGS10
H679023060070SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698206433210886982064332

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
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277681231MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681248MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681255MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681262MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681279MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681286MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681293MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681309MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681316MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681323MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681330MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681347MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277681354MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-03-01
10888277680463MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680616MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681026MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681071MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277681392MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-31
10888277680456MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680470MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680487MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680494MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680500MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680517MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680524MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680531MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680548MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680555MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680562MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29
10888277680579MEDLINEMEDLINE INDUSTRIES, INC.JEC2025-01-29