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FDA 510(k)

SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE

K-Number: K011954 · 2001-09-19

ApplicantSulzer Orthopedics, Inc.
Decision Date2001-09-19
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Orthopedics, Inc.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K011954. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE?

SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K011954.

When did SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE receive FDA 510(k) clearance?

SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE received FDA 510(k) clearance on 2001-09-19, under 510(k) number K011954.

Who is the listed applicant for SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE?

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

What is the FDA product code for SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE?

The FDA product code for SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE is HSX.

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Other records listing Sulzer Orthopedics, Inc. as applicant

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Related Devices (Code: HSX)

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.

K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, 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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