FDA 510(k)

STRYKER PATIENT SPECIFIC POLYMER IMPLANT

K-Number: K103010 · 2010-10-26

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2010-10-26

Product CodeKKY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

STRYKER PATIENT SPECIFIC POLYMER IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2010-10-26 under 510(k) number K103010. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER PATIENT SPECIFIC POLYMER IMPLANT?

STRYKER PATIENT SPECIFIC POLYMER IMPLANT is a medical device that received FDA 510(k) clearance on 2010-10-26. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K103010.

When did STRYKER PATIENT SPECIFIC POLYMER IMPLANT receive FDA 510(k) clearance?

STRYKER PATIENT SPECIFIC POLYMER IMPLANT received FDA 510(k) clearance on 2010-10-26, under 510(k) number K103010.

Who is the listed applicant for STRYKER PATIENT SPECIFIC POLYMER IMPLANT?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER PATIENT SPECIFIC POLYMER IMPLANT?

The FDA product code for STRYKER PATIENT SPECIFIC POLYMER IMPLANT is KKY.

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 Howmedica Osteonics Corp., Dba Stryker Orthopaedics as applicant

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper K252044Triathlon® Total Knee System - Triathlon® Gold Femoral Components K250989Stryker and Serf hip devices

View all 33 devices →

Related Devices (Code: KKY)

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLC K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USA K111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSynthes, Inc.K080507AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANTCeremed , 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.