FDA.reportPublic FDA data

Alteon

Primary DI
10885862514141
Brand
Alteon
Company
Exactech, Inc.
Model
191-13-11
Catalog number
191-13-11
Device description
ALT HA S DMND BRCH SZ 11
Published
2022-08-18
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
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
K162732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162732000Exactech® Alteon® HA Femoral StemExactech, Inc.2017-04-26MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862514141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586251414110885862514141

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Device Sizes#

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

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
10885862660527AcuMatch103-61-00103-61-002026-05-28
10885862660541AcuMatch103-61-07103-61-072026-05-28
10885862660558AcuMatch103-61-10103-61-102026-05-28
10885862660565AcuMatch103-61-97103-61-972026-05-28
10885862663207N/A101-14-00101-14-002026-05-28
10885862656117Newton02-521-90-200402-521-90-20042026-05-27
10885862656124Newton02-521-90-200502-521-90-20052026-05-27
10885862656131Newton02-521-90-200602-521-90-20062026-05-27
10885862656148Newton02-521-90-200702-521-90-20072026-05-27
10885862656155Newton02-521-90-200802-521-90-20082026-05-27
10885862656162Newton02-521-90-200902-521-90-20092026-05-27
10885862656179Newton02-521-90-201002-521-90-20102026-05-27
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
10885862653765Alteon190-00-08190-00-082026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843575126801Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126818Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126825Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126832Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126849Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126856Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126863Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126870Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126887Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126894Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126900Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126917Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126924Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126931Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126948Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126955Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126962Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126979Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126986Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128621Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128638Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128645Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128652Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575128669Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
07611996142334POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996103410POLARSTEMSmith & Nephew, Inc.MEH2016-07-25