FDA.reportPublic FDA data

N/A

Primary DI
00841036272203
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
323.0071
Catalog number
323.0071
Published
2019-09-23
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
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141241000
K183317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141241000MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEMSynthes (USA) Products, LLC2014-08-07HRS
K183317000AdvantageRib SystemSig Medical Corporation2019-02-14HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854865007335PreviousGS10
00841036272203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854865007335008548650073358548650073350854865007335
00841036272203008410362722038410362722030841036272203

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
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
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
10850070500132CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500149CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500156CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500163CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500170CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500187CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500194CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500200CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500217CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500224CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500231CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500248CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500255CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500262CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500279CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500286CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
10850070500293CurvaFix® Low Profile ImplantCURVAFIX, INC.HWC2025-10-22
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