FDA.reportPublic FDA data

Plate Cutter

Primary DI
00851599007259
Brand
Plate Cutter
Company
JACE MEDICAL, LLC
Model
215.010.40
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXZCutter, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851599007259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851599007259008515990072598515990072590851599007259

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
063554875
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853190008895Universal Plate Cutter215.010.422020-11-06
00851599007136Implant Positioner Handle, Standard215.010.012018-01-26
00850051329069Sternalock EZ315.110.152023-05-26
00853190008741Sternalock EZ115.107.122023-11-20
00851599007945Sternalock EZ315.010.002023-05-26
00853190008789Sternalock EZ115.302.162023-11-20
00853190008796Sternalock EZ115.401.042023-11-20
00851599007396Plate Screw Guide201.025.002016-11-18
00851599007983Sternalock EZ315.010.202023-05-26
00851599007655T15 Hexalobe Drive201.047.152018-01-26
00850051329014Sternalock EZ115.504.122023-11-20
00850051329021Sternalock EZ115.505.122023-11-20
00853190008352Sternalock EZ115.503.082023-11-20
00853190008512Sternalock EZ115.101.042023-11-20
00853190008529Sternalock EZ115.102.062023-11-20
00853190008635Sternalock EZ115.103.042023-11-20
00853190008642Sternalock EZ115.104.062023-11-20
00853190008727Sternalock EZ115.105.102023-11-20
00853190008734Sternalock EZ115.106.102023-11-20
00853190008758Sternalock EZ115.109.082023-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20757770457766Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457773Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457780Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09
00810118108051NuSmile Hard Wire CutterNUSMILE, LTD.HXZ2026-04-08
00192896122994Table Top Rod CutterSONTEC INSTRUMENTS, INC.HXZ2026-03-31
00841506142364GeminusSKELETAL DYNAMICS L.L.C.HXZ2026-01-21
00192896122529Crimper/CutterSONTEC INSTRUMENTS, INC.HXZ2025-11-21
00199150050888Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXZ2025-11-20
D90980001641ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D90980001651ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D9098000331SPECTRUMOrtho Arch Company IncHXZ2025-09-15
D90980021311RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021412RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021513RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021715RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021816RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021917RAZOROrtho Arch Company IncHXZ2025-09-15
D90980022312RAZOROrtho Arch Company IncHXZ2025-09-15
00841435124912TecometTECOMET INC.HXZ2025-09-05
00190776409432MillenniumAvalign Technologies, Inc.HXZ2025-09-02
10818674026298Knotless flush cutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-12
10818674025994Multi Suture CutterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXZ2025-08-11
00190776407766MillenniumAvalign Technologies, Inc.HXZ2025-08-01
00194613013912MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013929MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013936MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013943MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613013950MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01
00194613015893MSI Precision Specialty InstrumentsMed Saver, Inc.HXZ2025-08-01