FDA.reportPublic FDA data

AdvantageRib

Primary DI
00854865007168
Brand
AdvantageRib
Company
SIG MEDICAL CORP.
Model
323.1090
Catalog number
323.1090
Device description
AdvantageRib Guide Cable
Published
2018-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141241000MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEMSynthes (USA) Products, LLC2014-08-07HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854865007168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854865007168008548650071688548650071680854865007168

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
717-553-2021info@sigmedical.net

Regulatory Flags#

DUNS number
080503619
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854865007489AdvantageRib323.1010323.10102019-08-20
00854865007496AdvantageRib323.1011323.10112019-08-20
00854865007502AdvantageRib323.1012323.10122019-08-20
00854865007519AdvantageRib323.1013323.10132019-08-20
00854865007526AdvantageRib323.1020323.10202019-08-20
00854865007533AdvantageRib323.1021323.10212019-08-20
00854865007540AdvantageRib323.1022323.10222019-08-20
00854865007557AdvantageRib323.1023323.10232019-08-20
00854865007564AdvantageRib323.1030323.10302019-08-20
00854865007571AdvantageRib323.1031323.10312019-08-20
00854865007588AdvantageRib323.1032323.10322019-08-20
00854865007595AdvantageRib323.1033323.10332019-08-20
00854865007007AdvantageRib323.1001323.10012018-10-03
00854865007014AdvantageRib323.1002323.10022018-10-03
00854865007021AdvantageRib323.1003323.10032018-10-03
00854865007038AdvantageRib323.1004323.10042018-10-03
00854865007045AdvantageRib323.1005323.10052017-02-17
00854865007052AdvantageRib323.1006323.10062017-02-17
00854865007069AdvantageRib323.1007323.10072017-02-17
00854865007076AdvantageRib104.517.0102017-02-17

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