FDA.reportPublic FDA data

Alteon

Primary DI
10885862653765
Brand
Alteon
Company
Exactech, Inc.
Model
190-00-08
Catalog number
190-00-08
Device description
Femoral Stem, Press-Fit, Standard Offset, Cementless, HA Coated, Collarless, Traditional Length, Size 8
Published
2026-05-26
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

Product Codes#

Code, Name table
CodeName
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243839000Alteon® HA Femoral StemsExactech, Inc.2025-03-10MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862653765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586265376510885862653765

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653772Alteon190-00-09190-00-092026-05-26
10885862653789Alteon190-00-10190-00-102026-05-26
10885862653796Alteon190-00-11190-00-112026-05-26
10885862653802Alteon190-00-12190-00-122026-05-26
10885862653819Alteon190-00-13190-00-132026-05-26
10885862653826Alteon190-00-14190-00-142026-05-26
10885862653833Alteon190-00-15190-00-152026-05-26
10885862653840Alteon190-01-02190-01-022026-05-26
10885862653857Alteon190-01-03190-01-032026-05-26
10885862653864Alteon190-01-04190-01-042026-05-26
10885862653871Alteon190-01-05190-01-052026-05-26
10885862653888Alteon190-01-06190-01-062026-05-26
10885862653895Alteon190-01-07190-01-072026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862653697AlteonExactech, Inc.MEH2026-05-26
10885862653703AlteonExactech, Inc.MEH2026-05-26
10885862653710AlteonExactech, Inc.MEH2026-05-26
10885862653727AlteonExactech, Inc.MEH2026-05-26
10885862653734AlteonExactech, Inc.MEH2026-05-26
10885862653741AlteonExactech, Inc.MEH2026-05-26
10885862653758AlteonExactech, Inc.MEH2026-05-26
10885862653772AlteonExactech, Inc.MEH2026-05-26
10885862653789AlteonExactech, Inc.MEH2026-05-26
10885862653796AlteonExactech, Inc.MEH2026-05-26
10885862653802AlteonExactech, Inc.MEH2026-05-26
10885862653819AlteonExactech, Inc.MEH2026-05-26
10885862653826AlteonExactech, Inc.MEH2026-05-26
10885862653833AlteonExactech, Inc.MEH2026-05-26
10885862653840AlteonExactech, Inc.MEH2026-05-26
10885862653857AlteonExactech, Inc.MEH2026-05-26
10885862653864AlteonExactech, Inc.MEH2026-05-26
10885862653871AlteonExactech, Inc.MEH2026-05-26
10885862653888AlteonExactech, Inc.MEH2026-05-26
10885862653895AlteonExactech, Inc.MEH2026-05-26
10885862653901AlteonExactech, Inc.MEH2026-05-26
10885862653918AlteonExactech, Inc.MEH2026-05-26
10885862653925AlteonExactech, Inc.MEH2026-05-26
10885862653932AlteonExactech, Inc.MEH2026-05-26
10885862653949AlteonExactech, Inc.MEH2026-05-26
10885862653956AlteonExactech, Inc.MEH2026-05-26
10885862653963AlteonExactech, Inc.MEH2026-05-26
10885862653970AlteonExactech, Inc.MEH2026-05-26
10885862653987AlteonExactech, Inc.MEH2026-05-26
10885862653994AlteonExactech, Inc.MEH2026-05-26