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

FDA 510(k)

TEMA Elbow system - Line extension

K-Number: K222807 · 2022-10-26

ApplicantLima Corporate S.P.A.
Decision Date2022-10-26
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TEMA Elbow system - Line extension is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2022-10-26 under approval number K222807. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMA Elbow system - Line extension?

TEMA Elbow system - Line extension is a medical device that received FDA 510(k) clearance on 2022-10-26. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K222807.

When was TEMA Elbow system - Line extension approved by the FDA?

TEMA Elbow system - Line extension received FDA 510(k) clearance on 2022-10-26, under approval number K222807.

What company makes TEMA Elbow system - Line extension?

TEMA Elbow system - Line extension is manufactured by Lima Corporate S.P.A..

What is the FDA product code for TEMA Elbow system - Line extension?

The FDA product code for TEMA Elbow system - Line extension is JDB.

Related Clinical Trials

NCT06657183 ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy RECRUITING NCT03487250 Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT05101460 An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant ACTIVE_NOT_RECRUITING NCT07520851 Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal RECRUITING

Other Devices by Lima Corporate S.P.A.

K160011H-Max S stem K161476SMR Shoulder System K153722SMR 3-Pegs Glenoids K170473C2 femoral stem K163397SMR Hybrid Glenoid System K161120SMR TT Metal Back Glenoid, Bone Graft instruments

View all 41 devices →

Related Devices (Code: JDB)

K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc. K193247LATITUDE EV™ Total Elbow ArthroplastyTornier, 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.

↑