FDA.reportPublic FDA data

Vantage®, Activit-E

Primary DI
10885862631671
Brand
Vantage®, Activit-E
Company
Exactech, Inc.
Model
03-CNB-LN-0000
Catalog number
03-CNB-LN-0000
Device description
Tibial Liner Inserter Handle
Published
2024-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232002000Vantage® Total Ankle SystemExactech, Inc.2023-09-11HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862631671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586263167110885862631671

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
00840097514789Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514796Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514802Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514819Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514826Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514833Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514840Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514857Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514864Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514871Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514888Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514895Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514901Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514918Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097515694Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097515700Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097515717Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097533742Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097533759Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097533766Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097534046Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097536651Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097534237Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534244Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534251Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534268Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534275Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00840097534282Kinos Aeros Total Ankle ReplacementRestor3d, Inc.HSN2026-07-31
00889797111089PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797111096PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23