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FDA 510(k)

ASCENSION SILICONE PIP

K-Number: K082231 · 2009-01-12

ApplicantAscension Orthopedics, Inc.
Decision Date2009-01-12
Product CodeKYJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENSION SILICONE PIP 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 2009-01-12 under 510(k) number K082231. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCENSION SILICONE PIP?

ASCENSION SILICONE PIP is a medical device that received FDA 510(k) clearance on 2009-01-12. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K082231.

When did ASCENSION SILICONE PIP receive FDA 510(k) clearance?

ASCENSION SILICONE PIP received FDA 510(k) clearance on 2009-01-12, under 510(k) number K082231.

Who is the listed applicant for ASCENSION SILICONE PIP?

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 SILICONE PIP?

The FDA product code for ASCENSION SILICONE PIP is KYJ.

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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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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: KYJ)

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.

K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc.K220142BRM Digitalis SpacerBrm Extremities SrlK211385KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SAK083107MODIFICATION TO DEPUY NEUFLEX PIP FINGERDePuy Orthopaedics, Inc.K022892ASCENSION SILLICONE MCPAscension Orthopedics, Inc.K013629FINGER JOINT PROSTHESISAvanta Orthopaedics, 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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