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FDA 510(k)

SEVIIN FRACTURE SHOULDER

K-Number: K131277 · 2013-08-28

ApplicantIngen Orthopedics, LLC
Decision Date2013-08-28
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SEVIIN FRACTURE SHOULDER is the device name listed in this FDA 510(k) record. The listed applicant is Ingen Orthopedics, LLC. It received FDA 510(k) clearance on 2013-08-28 under 510(k) number K131277. 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 SEVIIN FRACTURE SHOULDER?

SEVIIN FRACTURE SHOULDER is a medical device that received FDA 510(k) clearance on 2013-08-28. The listed applicant is Ingen Orthopedics, LLC. The 510(k) number is K131277.

When did SEVIIN FRACTURE SHOULDER receive FDA 510(k) clearance?

SEVIIN FRACTURE SHOULDER received FDA 510(k) clearance on 2013-08-28, under 510(k) number K131277.

Who is the listed applicant for SEVIIN FRACTURE SHOULDER?

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

What is the FDA product code for SEVIIN FRACTURE SHOULDER?

The FDA product code for SEVIIN FRACTURE SHOULDER is KWS.

Related Clinical Trials

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 Ingen Orthopedics, LLC 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.

K130635SEVIIN SURFACE REPLACEMENT SHOULDERK120374SEVIIN REVERSE SHOULDER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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