FDA 510(k)

TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION

K-Number: K071090 · 2007-06-29

ApplicantZimmer Trabecular Metal Technology

Decision Date2007-06-29

Product CodeKWS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular Metal Technology. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K071090. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION?

TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Zimmer Trabecular Metal Technology. The 510(k) number is K071090.

When did TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION receive FDA 510(k) clearance?

TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION received FDA 510(k) clearance on 2007-06-29, under 510(k) number K071090.

Who is the listed applicant for TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION?

The FDA 510(k) record lists Zimmer Trabecular Metal Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION?

The FDA product code for TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION is KWS.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Zimmer Trabecular Metal Technology as applicant

K123602TM ARDIS INTERBODY SYSTEM INSERTER K120990NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL K113561TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION K111983VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX K103033TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX K102896TRABECULAR METAL TIBIAL CONE AUGMENTS

View all 10 devices →

Related Devices (Code: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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.