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FDA 510(k)

SYNTHES 6.0 COCR AND CPT TI-3 RODS

K-Number: K103287 · 2011-01-05

ApplicantSynthes Spine
Decision Date2011-01-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 6.0 COCR AND CPT TI-3 RODS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2011-01-05 under 510(k) number K103287. 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 SYNTHES 6.0 COCR AND CPT TI-3 RODS?

SYNTHES 6.0 COCR AND CPT TI-3 RODS is a medical device that received FDA 510(k) clearance on 2011-01-05. The listed applicant is Synthes Spine. The 510(k) number is K103287.

When did SYNTHES 6.0 COCR AND CPT TI-3 RODS receive FDA 510(k) clearance?

SYNTHES 6.0 COCR AND CPT TI-3 RODS received FDA 510(k) clearance on 2011-01-05, under 510(k) number K103287.

Who is the listed applicant for SYNTHES 6.0 COCR AND CPT TI-3 RODS?

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

What is the FDA product code for SYNTHES 6.0 COCR AND CPT TI-3 RODS?

The FDA product code for SYNTHES 6.0 COCR AND CPT TI-3 RODS is NKB.

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Other records listing Synthes Spine as applicant

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Related Devices (Code: 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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