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FDA 510(k)

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

K-Number: K112197 · 2011-11-17

ApplicantMemometal Technologies
Decision Date2011-11-17
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEMOMETAL INTRA-MEDULLARY BONE FASTENER is the device name listed in this FDA 510(k) record. The listed applicant is Memometal Technologies. It received FDA 510(k) clearance on 2011-11-17 under 510(k) number K112197. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEMOMETAL INTRA-MEDULLARY BONE FASTENER?

MEMOMETAL INTRA-MEDULLARY BONE FASTENER is a medical device that received FDA 510(k) clearance on 2011-11-17. The listed applicant is Memometal Technologies. The 510(k) number is K112197.

When did MEMOMETAL INTRA-MEDULLARY BONE FASTENER receive FDA 510(k) clearance?

MEMOMETAL INTRA-MEDULLARY BONE FASTENER received FDA 510(k) clearance on 2011-11-17, under 510(k) number K112197.

Who is the listed applicant for MEMOMETAL INTRA-MEDULLARY BONE FASTENER?

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

What is the FDA product code for MEMOMETAL INTRA-MEDULLARY BONE FASTENER?

The FDA product code for MEMOMETAL INTRA-MEDULLARY BONE FASTENER is HTY.

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Other records listing Memometal Technologies 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.

K101930MEMOMETAL NAVIS BONE PLATING SYSTEMK102072MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)K093820SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115K083447MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50K071941MEMOMETAL BONE ANCHORSK070598MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE

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Related Devices (Code: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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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