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510(k) K955271

Device
MICRO-SEAL ACETABULAR SYSTEM
Applicant
WHITESIDE INSTRUMENTS
510(k) number
K955271
Product code
LPH  
Decision
Substantially Equivalent (SESE)
Decision date
1996-01-30
Date received
1995-11-15
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

Related Records

Applicant Contact

Contact
MICHAEL C WALL
Address
12634 Olive Blvd. Creve Coeur MO US 63141 63141

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
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B046WB11184Microseal Augmented 20 Degree LinerSIGNAL MEDICAL CORPORATION2018-07-30
B046WB110880Micro Seal Anatomic 10 Degree LinerSIGNAL MEDICAL CORPORATION2017-10-10
B046WB111250Micro Seal Augmented 20 Degree LinerSIGNAL MEDICAL CORPORATION2017-08-14
B046WB110820Micro Seal Anatomic 10 Degree LinerSIGNAL MEDICAL CORPORATION2017-08-14
B046WB110790Micro Seal Anatomic 10 Degree LinerSIGNAL MEDICAL CORPORATION2017-08-14
B046WB110710Micro Seal Anatomic 10 Degree LinerSIGNAL MEDICAL CORPORATION2017-08-14
B046WB110680Micro Seal Anatomic 10 Degree LinerSIGNAL MEDICAL CORPORATION2017-08-14
B046WB111210Microseal Augmented 20 Degree LinerSIGNAL MEDICAL CORPORATION2016-04-29
B046WB111190Microseal Augmented 20 Degree LinerSIGNAL MEDICAL CORPORATION2016-04-29
B046WB111160Microseal Augmented 20 Degree LinerSIGNAL MEDICAL CORPORATION2016-04-29
B046WB110780Microseal Anatomic 10 Degree LinerSIGNAL MEDICAL CORPORATION2016-04-29
B046WB110740Microseal Anatomic10 Degree LinerSIGNAL MEDICAL CORPORATION2016-04-29
B046WB110690Microseal Anatomic 10 Degree LinerSIGNAL MEDICAL CORPORATION2016-04-29
B046WB110630Microseal Anatomic 10 Degree LinerSIGNAL MEDICAL CORPORATION2016-04-29
B046WB110670Microseal Anatomic 10 Degree LinerSIGNAL MEDICAL CORPORATION2016-04-15
B046WB111130Microseal Augmented 20 Degree LinerSIGNAL MEDICAL CORPORATION2016-03-25
B046WB111180Micro Seal Augmented 20 Degree LinerSIGNAL MEDICAL CORPORATION2016-02-12
B046WB111380Micro Seal Augmented 20 Degree LinerSIGNAL MEDICAL CORPORATION2016-02-12

Other 510(k) Records For Product Code LPH  

510(k)DeviceApplicantDecision date
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
K242232Mpact 3D Metal Augments IIMedacta International S.A.2025-04-23
K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.2025-04-10
K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-02-06
K243977EMPHASYS Acetabular SystemDepuy Ireland UC2025-01-22
K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A2025-01-13
K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG2024-11-08

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FDA Review

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