FDA.reportPublic FDA data

Alignment Instrument, Single End, Left

Primary DI
00851599007440
Brand
Alignment Instrument, Single End, Left
Company
JACE MEDICAL, LLC
Model
201.040.01
Published
2016-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851599007440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851599007440008515990074408515990074400851599007440

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. 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

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