FDA.reportPublic FDA data

NA

Primary DI
00817577022751
Brand
NA
Company
Exactech, Inc.
Model
2100-0005
Catalog number
2100-0005
Device description
THREADED BENDING RODS
Published
2022-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153340000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153340000Epic Extremity Plate SystemEpic Extremity, LLC2016-02-09HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817577022751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817577022751008175770227518175770227510817577022751

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
157565946
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862032102Novation160-20-11160-20-112015-08-10
10885862064035Optetrak244-24-09244-24-092015-10-30
10885862307132Truliant02-022-49-251102-022-49-25112017-05-16
10885862313058Optetrak Logic02-012-44-260902-012-44-26092017-02-16
10885862313065Optetrak Logic02-012-44-261102-012-44-26112017-02-16
10885862313072Optetrak Logic02-012-44-261302-012-44-26132017-02-16
10885862313089Optetrak Logic02-012-44-261502-012-44-26152017-02-16
10885862313218Optetrak Logic02-012-35-210902-012-35-21092017-02-16
10885862313225Optetrak Logic02-012-35-211102-012-35-21112017-02-16
10885862313232Optetrak Logic02-012-35-211302-012-35-21132017-02-16
10885862316271Optetrak Logic02-012-35-211702-012-35-21172017-02-16
10885862316288Optetrak Logic02-012-35-211902-012-35-21192017-02-16
10885862316356Optetrak Logic02-012-44-261702-012-44-26172017-02-16
10885862316363Optetrak Logic02-012-44-261902-012-44-26192017-02-16
10885862135049NAT2-5052T2-50522022-09-19
10885862135056NAT2-5458T2-54582022-09-19
10885862135063NAT2-6064T2-60642022-09-19
10885862135070NAT2-6670T2-66702022-09-19
10885862135636NAT8-4448T8-44482022-09-19
10885862135643NAT8-5052T8-50522022-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986482501CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482518CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482525CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482532CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482549CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482556CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482563CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482570CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482587CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
03700569602918Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602925Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602932Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602949Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602956Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602963Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602970Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602987Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
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00885556819869Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819876Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819883Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819890Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819906Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556846599Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-27
00885556910245UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-27
00885556819722Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819746Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819760Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819784UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26