FDA.reportPublic FDA data

Acumatch P Series

Primary DI
10885862017765
Brand
Acumatch P Series
Company
Exactech, Inc.
Model
114-23-01
Catalog number
114-23-01
Published
2015-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002141000ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FITExactech, Inc.2000-08-16LWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862017765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586201776510885862017765

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length135Millimeter

Regulatory Flags#

DUNS number
157565946
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862088130Equinoxe321-98-08321-98-082022-10-04
10885862086075NA315-98-43315-98-432022-09-20
10885862086082NA315-98-44315-98-442022-09-20
10885862086099NA315-98-45315-98-452022-09-20
10885862086105NA315-98-46315-98-462022-09-20
10885862086112NA315-98-47315-98-472022-09-20
10885862086129NA315-98-48315-98-482022-09-20
10885862086136NA315-98-49315-98-492022-09-20
10885862086143NA315-98-50315-98-502022-09-20
10885862086150NA315-98-51315-98-512022-09-20
10885862086167NA315-98-52315-98-522022-09-20
10885862086174NA315-98-53315-98-532022-09-20
10885862086181NA315-98-54315-98-542022-09-20
10885862253620GPS521-78-03521-78-032022-09-19
10885862052162NA205-55-09205-55-092022-08-25
10885862052179NA205-55-11205-55-112022-08-25
10885862052186NA205-55-13205-55-132022-08-25
10885862052193NA205-55-15205-55-152022-08-25
10885862085733Equinoxe315-98-01315-98-012022-08-18
10885862085740Equinoxe315-98-02315-98-022022-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14