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FDA 510(k)

UNITED STEM, PSA TYPE

K-Number: K100981 · 2010-06-14

ApplicantUnited Orthopedic Corp.
Decision Date2010-06-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITED STEM, PSA TYPE is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corp.. It received FDA 510(k) clearance on 2010-06-14 under 510(k) number K100981. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITED STEM, PSA TYPE?

UNITED STEM, PSA TYPE is a medical device that received FDA 510(k) clearance on 2010-06-14. The listed applicant is United Orthopedic Corp.. The 510(k) number is K100981.

When did UNITED STEM, PSA TYPE receive FDA 510(k) clearance?

UNITED STEM, PSA TYPE received FDA 510(k) clearance on 2010-06-14, under 510(k) number K100981.

Who is the listed applicant for UNITED STEM, PSA TYPE?

The FDA 510(k) record lists United Orthopedic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNITED STEM, PSA TYPE?

The FDA product code for UNITED STEM, PSA TYPE is JWH.

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Other records listing United Orthopedic Corp. 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.

K132455U-MOTION II PS+ CUPK122185U-MOTION II ACETABULAR SYSTEMK122183AUGMENT AND SCREW, PSA TYPEK121777U2 ACETABULAR CUP, PLASMA SPRAYK111546U2 HIP SYSTEMK103497CERAMIC FEMORAL HEAD

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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