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FDA 510(k)

TRIPORE, MODELS HA, BP90, BP15

K-Number: K070132 · 2007-07-13

ApplicantOrthogem Limited
Decision Date2007-07-13
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIPORE, MODELS HA, BP90, 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 2007-07-13 under 510(k) number K070132. 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, MODELS HA, BP90, BP15?

TRIPORE, MODELS HA, BP90, BP15 is a medical device that received FDA 510(k) clearance on 2007-07-13. The listed applicant is Orthogem Limited. The 510(k) number is K070132.

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

TRIPORE, MODELS HA, BP90, BP15 received FDA 510(k) clearance on 2007-07-13, under 510(k) number K070132.

Who is the listed applicant for TRIPORE, MODELS HA, BP90, 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, MODELS HA, BP90, BP15?

The FDA product code for TRIPORE, MODELS HA, BP90, 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.

K110787TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)

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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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