FDA.reportPublic FDA data

NA

Primary DI
07611819244726
Brand
NA
Company
Synthes GmbH
Model
329.151
Catalog number
329151
Device description
LOCKING CALCANEAL PLATE CUTTER
Published
2018-07-18
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
07611819244726Direct MarkingGS10
10886982191854PrimaryGS10
H6793291510SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819244726076118192447267611819244726
1088698219185410886982191854

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
486711679
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
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18
07649988948701SPIRECUTSPIRECUT SAHTZ2026-05-04
07649988948718SPIRECUTSPIRECUT SAHTZ2026-05-04
00196449033454Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033461Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033591Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449033676Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034185Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034192Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034208Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034673Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034680Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
00196449034697Anatomic Access LLIFTyber Medical, LLCHTZ2025-10-22
B471293000100GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000150GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000200GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
B471293000250GEO-DesisGRAMERCY EXTREMITY ORTHOPEDICS LLCHTZ2025-01-17
10886982339492NASynthes GmbHHTZ2024-10-09
10887587077611NASynthes GmbHHTZ2024-08-21
07898506814107QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506814114QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841677QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841691QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841707QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841714QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841752QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506848959QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506849413QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506849420QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506814329QuinelatoSchobell Industrial LtdaHTZ2022-12-16