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FDA 510(k)

ASFORA BULLET CAGE SYSTEM

K-Number: K090048 · 2009-08-14

ApplicantMedical Designs, LLC
Decision Date2009-08-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASFORA BULLET CAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Designs, LLC. It received FDA 510(k) clearance on 2009-08-14 under 510(k) number K090048. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASFORA BULLET CAGE SYSTEM?

ASFORA BULLET CAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-08-14. The listed applicant is Medical Designs, LLC. The 510(k) number is K090048.

When did ASFORA BULLET CAGE SYSTEM receive FDA 510(k) clearance?

ASFORA BULLET CAGE SYSTEM received FDA 510(k) clearance on 2009-08-14, under 510(k) number K090048.

Who is the listed applicant for ASFORA BULLET CAGE SYSTEM?

The FDA 510(k) record lists Medical Designs, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASFORA BULLET CAGE SYSTEM?

The FDA product code for ASFORA BULLET CAGE SYSTEM is MAX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Medical Designs, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182352SP-LINK™ SystemK181591Fixated Asfora BULLET CAGE® (FABC)K112648ASFORA BULLET CAGEK042359SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CALK002970SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Official Source

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

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