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Howmedica Insignia™ Hip Stem - HSA Registration DE0508334

Access comprehensive regulatory information for Howmedica Insignia™ Hip Stem in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508334 and owned by Howmedica Osteonics Corp.. The device was registered on July 27, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0508334
Howmedica Insignia™ Hip Stem
HSA Registration Number: DE0508334
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Product Description

Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis; Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure; Correction of functional deformity; Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication with Howmedica Osteonics Constrained Liners: The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. Additional indication with ADM and MDM Acetabular Components: The device is indicated for Dislocation risks. Insignia Hip Stems are intended for cementless use only & are intended for total and hemiarthroplasty procedures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0508334
Registration Date
July 27, 2023
Change Notification Approval Date
November 15, 2024
Retention Due Date
July 26, 2025
Product Owner
Short Name
Howmedica
Address
325 Corporate Drive, Mahwah, NJ 07430, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 0 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 1 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 2 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 3 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 4 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 5 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 6 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 7 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 8 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 9 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 10 INSIGNIA HIP STEM - STANDARD OFFSET, SIZE 11 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 0 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 1 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 2 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 3 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 4 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 5 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 6 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 7 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 8 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 9 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 10 INSIGNIA HIP STEM - HIGH OFFSET, SIZE 11 INSIGNIA HIP STEM STANDARD NECK TRIAL 0/1 INSIGNIA HIP STEM STANDARD NECK TRIAL 2/3/4 INSIGNIA HIP STEM STANDARD NECK TRIAL 5/6 INSIGNIA HIP STEM STANDARD NECK TRIAL 7/8/9 INSIGNIA HIP STEM STANDARD NECK TRIAL 10/11 INSIGNIA HIP STEM HIGH NECK TRIAL 0/1 INSIGNIA HIP STEM HIGH NECK TRIAL 2/3/4 INSIGNIA HIP STEM HIGH NECK TRIAL 5/6 INSIGNIA HIP STEM HIGH NECK TRIAL 7/8/9 INSIGNIA HIP STEM HIGH NECK TRIAL 10/11 INSIGNIA HIP STEM BROACH SIZE 0 INSIGNIA HIP STEM BROACH SIZE 1 INSIGNIA HIP STEM BROACH SIZE 2 INSIGNIA HIP STEM BROACH SIZE 3 INSIGNIA HIP STEM BROACH SIZE 4 INSIGNIA HIP STEM BROACH SIZE 5 INSIGNIA HIP STEM BROACH SIZE 6 INSIGNIA HIP STEM BROACH SIZE 7 INSIGNIA HIP STEM BROACH SIZE 8 INSIGNIA HIP STEM BROACH SIZE 9 INSIGNIA HIP STEM BROACH SIZE 10 INSIGNIA HIP STEM BROACH SIZE 11
Model Identifier(s)
7000-5500 7000-5501 7000-5502 7000-5503 7000-5504 7000-5505 7000-5506 7000-5507 7000-5508 7000-5509 7000-5510 7000-5511 7000-6600 7000-6601 7000-6602 7000-6603 7000-6604 7000-6605 7000-6606 7000-6607 7000-6608 7000-6609 7000-6610 7000-6611 7555-0001 7555-0002 7555-0003 7555-0004 7555-0005 7555-0006 7555-0007 7555-0008 7555-0009 7555-0010 8000-7700 8000-7701 8000-7702 8000-7703 8000-7704 8000-7705 8000-7706 8000-7707 8000-7708 8000-7709 8000-7710 8000-7711