FDA.reportPublic FDA data

NA

Primary DI
07611819753136
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
391.990
Catalog number
391990
Device description
PLATE/ROD CUTTER
Published
2017-10-13
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
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819753136Direct MarkingGS10
10887587041087PrimaryGS10
H9803919900SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819753136076118197531367611819753136
1088758704108710887587041087

GMDN Terms#

Term, Definition table
TermDefinition
Bone fixation plate pliersA manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. 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
H981PDL432FNAPDL432PDL4322017-02-20
H981PDL434HNAPDL434PDL4342017-02-20
07611819995796NA03.820.144038201442016-12-31
07611819943490NAE5115-7E511572017-02-20
H679E51157P09NAE5115-7PE51157P2016-12-31
10886982293060NA04.045.260040452602025-01-31
10886982293237NA04.045.230040452302025-01-31
10886982293244NA04.045.232040452322025-01-31
10886982293251NA04.045.234040452342025-01-31
10886982293268NA04.045.236040452362025-01-31
10886982293275NA04.045.238040452382025-01-31
10886982293282NA04.045.240040452402025-01-31
10886982293299NA04.045.242040452422025-01-31
10886982293305NA04.045.244040452442025-01-31
10886982293312NA04.045.246040452462025-01-31
10886982293329NA04.045.248040452482025-01-31
10886982293336NA04.045.250040452502025-01-31
10886982293343NA04.045.252040452522025-01-31
10886982293350NA04.045.254040452542025-01-31
10886982293367NA04.045.256040452562025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810212930497SURGIPROSSurgipros, LLCHTZ2026-05-22
10603295553625ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553632ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553649ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553656ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
00190376538945Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376538952Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700885Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700892Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00840180544709General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
00840180544716General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
00840180544662General InstrumentsALPHATEC SPINE, INC.HTZ2025-12-31
10603295553663ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553670ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553687ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553694ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553700ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295554929ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
00196449033638Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033669Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033683Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033423Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033430Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033447Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033478Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033485Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033492Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033584Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033607Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033621Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02