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)

OSTEOMED TRAM

K-Number: K963394 · 1996-11-14

ApplicantOsteomed Corp.
Decision Date1996-11-14
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED TRAM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Corp.. It received FDA 510(k) clearance on 1996-11-14 under 510(k) number K963394. 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 OSTEOMED TRAM?

OSTEOMED TRAM is a medical device that received FDA 510(k) clearance on 1996-11-14. The listed applicant is Osteomed Corp.. The 510(k) number is K963394.

When did OSTEOMED TRAM receive FDA 510(k) clearance?

OSTEOMED TRAM received FDA 510(k) clearance on 1996-11-14, under 510(k) number K963394.

Who is the listed applicant for OSTEOMED TRAM?

The FDA 510(k) record lists Osteomed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTEOMED TRAM?

The FDA product code for OSTEOMED TRAM 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 Osteomed 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.

K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMK022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMK013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMK021618OSA RIGID INTERNAL FIXATION SYSTEM

View all 26 devices →

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.

↑