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FDA 510(k)

SPINAL INJECTION SYSTEM

K-Number: K083909 · 2009-03-18

ApplicantLaurimed, LLC
Decision Date2009-03-18
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPINAL INJECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laurimed, LLC. It received FDA 510(k) clearance on 2009-03-18 under 510(k) number K083909. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL INJECTION SYSTEM?

SPINAL INJECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-18. The listed applicant is Laurimed, LLC. The 510(k) number is K083909.

When did SPINAL INJECTION SYSTEM receive FDA 510(k) clearance?

SPINAL INJECTION SYSTEM received FDA 510(k) clearance on 2009-03-18, under 510(k) number K083909.

Who is the listed applicant for SPINAL INJECTION SYSTEM?

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

What is the FDA product code for SPINAL INJECTION SYSTEM?

The FDA product code for SPINAL INJECTION SYSTEM is BSP.

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Other records listing Laurimed, 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.

K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderK161101PolypVac Microdebrider (3.3mm and 4.0mm)K133133LAURIMED POLYPVAC MICRODEBRIDERK091818LAURIMED SPINAL INJECTION SYSTEMK090815PERCUTANEOUS DISCECTOMY SYSTEMK082194LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002

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Related Devices (Code: BSP)

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.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

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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