FDA 510(k)

TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX

K-Number: K103033 · 2011-01-10

ApplicantZimmer Trabecular Metal Technology

Decision Date2011-01-10

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular Metal Technology. It received FDA 510(k) clearance on 2011-01-10 under 510(k) number K103033. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX?

TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX is a medical device that received FDA 510(k) clearance on 2011-01-10. The listed applicant is Zimmer Trabecular Metal Technology. The 510(k) number is K103033.

When did TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX receive FDA 510(k) clearance?

TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX received FDA 510(k) clearance on 2011-01-10, under 510(k) number K103033.

Who is the listed applicant for TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX?

The FDA 510(k) record lists Zimmer Trabecular Metal Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX?

The FDA product code for TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX is ODP.

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Other records listing Zimmer Trabecular Metal Technology as applicant

K123602TM ARDIS INTERBODY SYSTEM INSERTER K120990NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL K113561TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION K111983VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX K102896TRABECULAR METAL TIBIAL CONE AUGMENTS K093127TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET

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Related Devices (Code: ODP)

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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.