FDA.report

Vantage®, Activit-E

Primary DI
10885862604231
Brand
Vantage®, Activit-E
Company
Exactech, Inc.
Model
350-24-31
Catalog number
350-24-31
Device description
Fixed Bearing Tibial Insert
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions

SubmissionSupplement
K232002000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885862604231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088586260423110885862604231

GMDN Terms

TermDefinition
Fixed-bearing total ankle prosthesisA sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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10885862648044Equinoxe313-01-41313-01-412026-03-19
10885862648051Equinoxe313-01-44313-01-442026-03-19
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10885862648075Equinoxe313-01-50313-01-502026-03-19
10885862648082Equinoxe313-01-53313-01-532026-03-19
10885862648099Equinoxe313-05-01313-05-012026-03-19
10885862648105Equinoxe313-05-02313-05-022026-03-19
10885862648129Equinoxe313-07-01313-07-012026-03-19
10885862648136Equinoxe313-07-02313-07-022026-03-19
10885862648143Equinoxe313-07-03313-07-032026-03-19
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10885862648167Equinoxe313-07-07313-07-072026-03-19
10885862648174Equinoxe313-07-10313-07-102026-03-19
10885862648259Equinoxe313-25-38313-25-382026-03-19
10885862648266Equinoxe313-25-41313-25-412026-03-19
10885862648273Equinoxe313-25-44313-25-442026-03-19
10885862648280Equinoxe313-25-47313-25-472026-03-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10885862655714VantageExactech, Inc.HSN2026-03-19
10885862656834VantageExactech, Inc.HSN2026-03-10
10885862656841VantageExactech, Inc.HSN2026-03-10
10885862656858VantageExactech, Inc.HSN2026-03-10
10885862656865VantageExactech, Inc.HSN2026-03-10
10885862656872VantageExactech, Inc.HSN2026-03-10
10885862656889VantageExactech, Inc.HSN2026-03-10
10885862656896VantageExactech, Inc.HSN2026-03-10
10885862656902VantageExactech, Inc.HSN2026-03-10
10885862656919VantageExactech, Inc.HSN2026-03-10
10885862656926VantageExactech, Inc.HSN2026-03-10
10885862656933VantageExactech, Inc.HSN2026-03-10
10885862656940VantageExactech, Inc.HSN2026-03-10
00889795154026APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-02-19
00840097533681Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097533698Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097533704Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097535951Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
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