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FDA 510(k)

TI-TAMED SPINAL SYSTEM

K-Number: K070385 · 2009-07-31

ApplicantTi-Tamed (Pty), Ltd.
Decision Date2009-07-31
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TI-TAMED SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ti-Tamed (Pty), Ltd.. It received FDA 510(k) clearance on 2009-07-31 under 510(k) number K070385. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TI-TAMED SPINAL SYSTEM?

TI-TAMED SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-31. The listed applicant is Ti-Tamed (Pty), Ltd.. The 510(k) number is K070385.

When did TI-TAMED SPINAL SYSTEM receive FDA 510(k) clearance?

TI-TAMED SPINAL SYSTEM received FDA 510(k) clearance on 2009-07-31, under 510(k) number K070385.

Who is the listed applicant for TI-TAMED SPINAL SYSTEM?

The FDA 510(k) record lists Ti-Tamed (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TI-TAMED SPINAL SYSTEM?

The FDA product code for TI-TAMED SPINAL SYSTEM is NKB.

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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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