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510(k) K993082

Device
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
Applicant
EXACTECH, INC.
510(k) number
K993082
Product code
LPH  
Decision
Substantially Equivalent (SESE)
Decision date
1999-11-19
Date received
1999-09-15
Regulation
888.3358
Classification name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GARY J MILLER
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LPH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261453G7® Acetabular SystemZimmer Biomet2026-09-23
K253630Mpact 3D Metal FoamMedacta International S.A.2026-08-28
K254043TRIVANCE™ Hip StemGlobus Medical, Inc.2026-08-04
K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics2026-07-10
K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC2026-06-05
K251270Taperloc® Complete Hip StemBiomet, Inc.2026-05-19
K252623G7® Revision Acetabular SystemZimmer, Inc.2026-02-04
K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.2026-01-28
K252067Velora Acetabular SystemRestor3D, Inc.2025-12-05
K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics2025-11-20
K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.2025-11-12
K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.2025-08-29
K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)2025-07-25
K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.2025-06-06
K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited2025-06-05

Legacy Summary#

summary

FDA Review#

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