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FDA 510(k)

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

K-Number: K241491 · 2024-10-10

ApplicantStryker Corporation (Tornier, S.A.S.)
Decision Date2024-10-10
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation (Tornier, S.A.S.). It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K241491. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid?

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Stryker Corporation (Tornier, S.A.S.). The 510(k) number is K241491.

When did Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid receive FDA 510(k) clearance?

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid received FDA 510(k) clearance on 2024-10-10, under 510(k) number K241491.

Who is the listed applicant for Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid?

The FDA 510(k) record lists Stryker Corporation (Tornier, S.A.S.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid?

The FDA product code for Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid is PHX.

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.

NCT05868148Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical StudyACTIVE_NOT_RECRUITING

Other records listing Stryker Corporation (Tornier, S.A.S.) 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.

K253674Blueprint Patient-Specific Instrumentation

Related Devices (Code: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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