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FDA 510(k)

ASCENSION PYROSPHERE CMC/TMT

K-Number: K060560 · 2006-05-05

ApplicantAscension Orthopedics, Inc.
Decision Date2006-05-05
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENSION PYROSPHERE CMC/TMT is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics, Inc.. It received FDA 510(k) clearance on 2006-05-05 under 510(k) number K060560. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCENSION PYROSPHERE CMC/TMT?

ASCENSION PYROSPHERE CMC/TMT is a medical device that received FDA 510(k) clearance on 2006-05-05. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K060560.

When did ASCENSION PYROSPHERE CMC/TMT receive FDA 510(k) clearance?

ASCENSION PYROSPHERE CMC/TMT received FDA 510(k) clearance on 2006-05-05, under 510(k) number K060560.

Who is the listed applicant for ASCENSION PYROSPHERE CMC/TMT?

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

What is the FDA product code for ASCENSION PYROSPHERE CMC/TMT?

The FDA product code for ASCENSION PYROSPHERE CMC/TMT is KWD.

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Other records listing Ascension 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.

K233674Freedom Wrist Arthroplasty SystemK233670Ascension Silicone MCP; Ascension Silicone PIPK121826INTEGRA PROXIMAL HUMERAL PLATE SYSTEMK110700ASCENSION ATLAS HUMERAL PLATING SYSTEMK102549THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYK100448ASCENSION MODULAR TOTAL SHOULDER SYSTEM

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Related Devices (Code: KWD)

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.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

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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