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FDA 510(k)

ASCENSION MODULAR TOTAL SHOULDER SYSTEM

K-Number: K100448 · 2010-08-30

ApplicantAscension Orthopedics, Inc.
Decision Date2010-08-30
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENSION MODULAR TOTAL SHOULDER SYSTEM 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 2010-08-30 under 510(k) number K100448. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCENSION MODULAR TOTAL SHOULDER SYSTEM?

ASCENSION MODULAR TOTAL SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-30. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K100448.

When did ASCENSION MODULAR TOTAL SHOULDER SYSTEM receive FDA 510(k) clearance?

ASCENSION MODULAR TOTAL SHOULDER SYSTEM received FDA 510(k) clearance on 2010-08-30, under 510(k) number K100448.

Who is the listed applicant for ASCENSION MODULAR TOTAL SHOULDER SYSTEM?

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 MODULAR TOTAL SHOULDER SYSTEM?

The FDA product code for ASCENSION MODULAR TOTAL SHOULDER SYSTEM is KWS.

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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 ARTHROPLASTYK100502ASCENSION TOTAL PLATE SYSTEM

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Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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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