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)

TIMESH TITANIUM MINI-SOFTPLATE/SCREW

K-Number: K923802 · 1992-10-26

ApplicantTi-Mesh, Inc.
Decision Date1992-10-26
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TIMESH TITANIUM MINI-SOFTPLATE/SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Ti-Mesh, Inc.. It received FDA 510(k) clearance on 1992-10-26 under 510(k) number K923802. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIMESH TITANIUM MINI-SOFTPLATE/SCREW?

TIMESH TITANIUM MINI-SOFTPLATE/SCREW is a medical device that received FDA 510(k) clearance on 1992-10-26. The listed applicant is Ti-Mesh, Inc.. The 510(k) number is K923802.

When did TIMESH TITANIUM MINI-SOFTPLATE/SCREW receive FDA 510(k) clearance?

TIMESH TITANIUM MINI-SOFTPLATE/SCREW received FDA 510(k) clearance on 1992-10-26, under 510(k) number K923802.

Who is the listed applicant for TIMESH TITANIUM MINI-SOFTPLATE/SCREW?

The FDA 510(k) record lists Ti-Mesh, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIMESH TITANIUM MINI-SOFTPLATE/SCREW?

The FDA product code for TIMESH TITANIUM MINI-SOFTPLATE/SCREW is JEY.

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 Ti-Mesh, Inc. 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.

K923419TISMESH SYSTEMK922308TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER

Related Devices (Code: JEY)

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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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.

↑