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FDA 510(k)

TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT

K-Number: K121509 · 2012-11-05

ApplicantTgm Medical, Inc.
Decision Date2012-11-05
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Tgm Medical, Inc.. It received FDA 510(k) clearance on 2012-11-05 under 510(k) number K121509. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT?

TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT is a medical device that received FDA 510(k) clearance on 2012-11-05. The listed applicant is Tgm Medical, Inc.. The 510(k) number is K121509.

When did TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT receive FDA 510(k) clearance?

TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT received FDA 510(k) clearance on 2012-11-05, under 510(k) number K121509.

Who is the listed applicant for TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT?

The FDA 510(k) record lists Tgm Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT?

The FDA product code for TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT is KWY.

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Other records listing Tgm Medical, Inc. 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.

K130084MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGMK121636ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERTK112285MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE...

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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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