FDA.reportPublic FDA data

AdvantageRib

Primary DI
00854865007335
Brand
AdvantageRib
Company
SIG MEDICAL CORP.
Model
323.0071
Catalog number
323.0071
Device description
Small Cannulated AO Quick-Connect Handle
Published
2018-10-03
Public version status
New
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
00854865007335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854865007335008548650073358548650073350854865007335

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889095401820ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
10886982350732VOLTSynthes GmbHHRS2026-09-25
10886982350749VOLTSynthes GmbHHRS2026-09-25
10886982350756VOLTSynthes GmbHHRS2026-09-25
10886982350763VOLTSynthes GmbHHRS2026-09-25
10886982350770VOLTSynthes GmbHHRS2026-09-25
10886982350787VOLTSynthes GmbHHRS2026-09-25
10886982350794VOLTSynthes GmbHHRS2026-09-25
10886982350800VOLTSynthes GmbHHRS2026-09-25
10886982350817VOLTSynthes GmbHHRS2026-09-25
10886982350824VOLTSynthes GmbHHRS2026-09-25
10886982350831VOLTSynthes GmbHHRS2026-09-25
10886982350848VOLTSynthes GmbHHRS2026-09-25
10886982350855VOLTSynthes GmbHHRS2026-09-25
10886982350862VOLTSynthes GmbHHRS2026-09-25
10886982350879VOLTSynthes GmbHHRS2026-09-25