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FDA 510(k)

SEVIIN SURFACE REPLACEMENT SHOULDER

K-Number: K130635 · 2013-08-26

ApplicantIngen Orthopedics, LLC
Decision Date2013-08-26
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SEVIIN SURFACE REPLACEMENT 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 2013-08-26 under 510(k) number K130635. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEVIIN SURFACE REPLACEMENT SHOULDER?

SEVIIN SURFACE REPLACEMENT SHOULDER is a medical device that received FDA 510(k) clearance on 2013-08-26. The listed applicant is Ingen Orthopedics, LLC. The 510(k) number is K130635.

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

SEVIIN SURFACE REPLACEMENT SHOULDER received FDA 510(k) clearance on 2013-08-26, under 510(k) number K130635.

Who is the listed applicant for SEVIIN SURFACE REPLACEMENT 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 SURFACE REPLACEMENT SHOULDER?

The FDA product code for SEVIIN SURFACE REPLACEMENT SHOULDER is HSD.

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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.

K131277SEVIIN FRACTURE SHOULDERK120374SEVIIN REVERSE SHOULDER

Related Devices (Code: HSD)

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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, 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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