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FDA 510(k)

TIGER DISCECTOMY DEVICE

K-Number: K081240 · 2009-02-27

ApplicantSpinal Devices, LLC
Decision Date2009-02-27
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TIGER DISCECTOMY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Devices, LLC. It received FDA 510(k) clearance on 2009-02-27 under 510(k) number K081240. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIGER DISCECTOMY DEVICE?

TIGER DISCECTOMY DEVICE is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Spinal Devices, LLC. The 510(k) number is K081240.

When did TIGER DISCECTOMY DEVICE receive FDA 510(k) clearance?

TIGER DISCECTOMY DEVICE received FDA 510(k) clearance on 2009-02-27, under 510(k) number K081240.

Who is the listed applicant for TIGER DISCECTOMY DEVICE?

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

What is the FDA product code for TIGER DISCECTOMY DEVICE?

The FDA product code for TIGER DISCECTOMY DEVICE is HRX.

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Other records listing Spinal Devices, 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.

K083167PHENIX CERVICAL INTERBODY DEVICE

Related Devices (Code: HRX)

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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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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