FDA.reportPublic FDA data

Implant Positioner Handle, Standard

Primary DI
00851599007136
Brand
Implant Positioner Handle, Standard
Company
JACE MEDICAL, LLC
Model
215.010.01
Published
2018-01-26
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851599007136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851599007136008515990071368515990071360851599007136

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft) or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). 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
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
00853190008765Sternalock EZ115.110.102023-11-20

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Primary DI, Brand, Company table
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