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FDA 510(k)

INTEGRITY SPINAL CARE SYSTEM

K-Number: K103248 · 2011-04-05

ApplicantIntegra Life Sciences
Decision Date2011-04-05
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INTEGRITY SPINAL CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra Life Sciences. It received FDA 510(k) clearance on 2011-04-05 under 510(k) number K103248. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRITY SPINAL CARE SYSTEM?

INTEGRITY SPINAL CARE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-05. The listed applicant is Integra Life Sciences. The 510(k) number is K103248.

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

INTEGRITY SPINAL CARE SYSTEM received FDA 510(k) clearance on 2011-04-05, under 510(k) number K103248.

Who is the listed applicant for INTEGRITY SPINAL CARE SYSTEM?

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

What is the FDA product code for INTEGRITY SPINAL CARE SYSTEM?

The FDA product code for INTEGRITY SPINAL CARE SYSTEM is ITH.

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Other records listing Integra Life Sciences 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.

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Related Devices (Code: ITH)

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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