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FDA 510(k)

TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)

K-Number: K110787 · 2011-04-21

ApplicantOrthogem Limited
Decision Date2011-04-21
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) is the device name listed in this FDA 510(k) record. The listed applicant is Orthogem Limited. It received FDA 510(k) clearance on 2011-04-21 under 510(k) number K110787. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)?

TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) is a medical device that received FDA 510(k) clearance on 2011-04-21. The listed applicant is Orthogem Limited. The 510(k) number is K110787.

When did TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) receive FDA 510(k) clearance?

TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) received FDA 510(k) clearance on 2011-04-21, under 510(k) number K110787.

Who is the listed applicant for TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)?

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

What is the FDA product code for TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)?

The FDA product code for TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) is MQV.

Related Clinical Trials

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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Other records listing Orthogem Limited 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.

K070132TRIPORE, MODELS HA, BP90, BP15

Related Devices (Code: MQV)

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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