FDA 510(k)

TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T

K-Number: K100210 · 2010-08-26

Decision Date2010-08-26

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T is the device name listed in this FDA 510(k) record. The listed applicant is Trans1 Incorporated. It received FDA 510(k) clearance on 2010-08-26 under 510(k) number K100210. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T?

TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T is a medical device that received FDA 510(k) clearance on 2010-08-26. The listed applicant is Trans1 Incorporated. The 510(k) number is K100210.

When did TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T receive FDA 510(k) clearance?

TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T received FDA 510(k) clearance on 2010-08-26, under 510(k) number K100210.

Who is the listed applicant for TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T?

The FDA 510(k) record lists Trans1 Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T?

The FDA product code for TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T is MAX.

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Other records listing Trans1 Incorporated as applicant

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Related Devices (Code: MAX)

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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.