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FDA 510(k)

MODIFICATION TO: PSS SYSTEM

K-Number: K092128 · 2009-09-14

ApplicantSpinal USA
Decision Date2009-09-14
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: PSS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal USA. It received FDA 510(k) clearance on 2009-09-14 under 510(k) number K092128. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: PSS SYSTEM?

MODIFICATION TO: PSS SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-14. The listed applicant is Spinal USA. The 510(k) number is K092128.

When did MODIFICATION TO: PSS SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: PSS SYSTEM received FDA 510(k) clearance on 2009-09-14, under 510(k) number K092128.

Who is the listed applicant for MODIFICATION TO: PSS SYSTEM?

The FDA 510(k) record lists Spinal USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: PSS SYSTEM?

The FDA product code for MODIFICATION TO: PSS SYSTEM is MNI.

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Other records listing Spinal USA 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.

K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICEK130863FACET SCREW SYSTEMK131343REFORM PEDICLE SCREW SYSTEMK130279REFORM PEDICLE SCREW SYSTEMK130445VAULT ALIF SYSTEMK122931S-LOK PSS SYSTEM

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Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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