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FDA 510(k)

Southern Implants MAX Implant System

K-Number: K191054 · 2019-12-09

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2019-12-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Southern Implants MAX Implant System is a medical device manufactured by Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2019-12-09 under approval number K191054. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Southern Implants MAX Implant System?

Southern Implants MAX Implant System is a medical device that received FDA 510(k) clearance on 2019-12-09. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K191054.

When was Southern Implants MAX Implant System approved by the FDA?

Southern Implants MAX Implant System received FDA 510(k) clearance on 2019-12-09, under approval number K191054.

What company makes Southern Implants MAX Implant System?

Southern Implants MAX Implant System is manufactured by Southern Implants (Pty), Ltd..

What is the FDA product code for Southern Implants MAX Implant System?

The FDA product code for Southern Implants MAX Implant System is DZE.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) PMID: 41620260 [Breast implants and cancer: Anaplastic large cell lymphoma in breast implants]. Annales de chirurgie plastique et esthetique (2026)

Other Devices by Southern Implants (Pty), Ltd.

K161548Osseointegrated Fixtures K163634External Hex Implants K163060Deep Conical (DC) Implants and Accessories K181850Inversa Implants K180465Provata Implant System K173706Piccolo Implants and Accessories

View all 19 devices →

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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