FDA.reportPublic FDA data

MatrixRIB

Primary DI
07611819614338
Brand
MatrixRIB
Company
SYNTHES (U.S.A.) LP
Model
03.501.091
Catalog number
03501091
Device description
COMBINATION BENDING PLIERS FOR MATRIXRIB
Published
2017-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXWBENDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819614338Direct MarkingGS10
10887587066912PrimaryGS10
H980035010910SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819614338076118196143387611819614338
1088758706691210887587066912

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable 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
832637081
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887587078496NASynthes GmbHHXW2026-08-26
00840536822871Response SpineORTHOPEDIATRICS CORP.HXW2026-08-21
00840536822888Response SpineORTHOPEDIATRICS CORP.HXW2026-08-21
00840536822895Response SpineORTHOPEDIATRICS CORP.HXW2026-08-21
00840536822901Response SpineORTHOPEDIATRICS CORP.HXW2026-08-21
10705034579627N/AMedos International SàrlHXW2026-08-14
10705034579634N/AMedos International SàrlHXW2026-08-14
00840606191654Overwatch PCFSPINAL ELEMENTS, INC.HXW2026-07-31
00840606191661Overwatch PCFSPINAL ELEMENTS, INC.HXW2026-07-31
00840606191760Overwatch PCFSPINAL ELEMENTS, INC.HXW2026-07-31
B8034709150ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709160ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709170ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709180ORTHOMEDORTHO-MED, INC.HXW2026-07-14
B8034709190ORTHOMEDORTHO-MED, INC.HXW2026-07-14
008401944958133P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958203P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958373P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958443P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
008401944958513P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXW2026-06-10
08800089476886Surgical InstrumentJeil Medical CorporationHXW2026-04-09
08800089476893Surgical InstrumentJeil Medical CorporationHXW2026-04-09
07640332475553CURE 2.0 ACPSpineArt SAHXW2025-11-12
07640375234834PERLA ® TLSpineArt SAHXW2025-11-10
07640375234841PERLA ® TLSpineArt SAHXW2025-11-10
07640375234858PERLA ® TLSpineArt SAHXW2025-11-10
07640375234865PERLA ® TLSpineArt SAHXW2025-11-10
08809695601781GSS™ and AnyPlus®GS Medical Co., Ltd.HXW2025-03-17
08809695630187GSS™ and AnyPlus®GS Medical Co., Ltd.HXW2025-03-17
08809885726911Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXW2025-03-17