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FDA 510(k)

FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT

K-Number: K981194 · 1998-06-30

ApplicantNexa Orthopedics, Inc.
Decision Date1998-06-30
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Nexa Orthopedics, Inc.. It received FDA 510(k) clearance on 1998-06-30 under 510(k) number K981194. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT?

FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT is a medical device that received FDA 510(k) clearance on 1998-06-30. The listed applicant is Nexa Orthopedics, Inc.. The 510(k) number is K981194.

When did FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT receive FDA 510(k) clearance?

FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT received FDA 510(k) clearance on 1998-06-30, under 510(k) number K981194.

Who is the listed applicant for FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT?

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

What is the FDA product code for FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT?

The FDA product code for FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT is KWH.

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Other records listing Nexa Orthopedics, 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.

K072710NEXFIX COMPRESSION PINK071147NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEMK070688NEXFIX COMPRESSION STAPLEK060386NEXA CARPO METACARPAL IMPLANTK060071NEXA COMPRESSION SCREWK053408NEXA BONE PLATE AND SCREW SYSTEM

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Related Devices (Code: KWH)

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.

K191966NewPrim SystemBrm ExtremitiesK190136Fusion Silastic SystemFusion Orthopedics, LLCK173491RTS Lesser MTP Implant SystemIn2bones USA, LLCK153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLCK102601ORTHOFLEX RODOrtho-Pro, LLCK023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTNexa Orthopedics, Inc.

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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