Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UNITED U2 BIPOLAR IMPLANT

K-Number: K101670 · 2010-10-08

ApplicantUnited Orthopedic Corp.
Decision Date2010-10-08
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITED U2 BIPOLAR IMPLANT 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 2010-10-08 under 510(k) number K101670. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITED U2 BIPOLAR IMPLANT?

UNITED U2 BIPOLAR IMPLANT is a medical device that received FDA 510(k) clearance on 2010-10-08. The listed applicant is United Orthopedic Corp.. The 510(k) number is K101670.

When did UNITED U2 BIPOLAR IMPLANT receive FDA 510(k) clearance?

UNITED U2 BIPOLAR IMPLANT received FDA 510(k) clearance on 2010-10-08, under 510(k) number K101670.

Who is the listed applicant for UNITED U2 BIPOLAR IMPLANT?

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 U2 BIPOLAR IMPLANT?

The FDA product code for UNITED U2 BIPOLAR IMPLANT is KWY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 18 devices →

Related Devices (Code: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical GmbH

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.

↑