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)

SONGER TITANIUM SPINE-L-ROD

K-Number: K854313 · 1985-11-15

ApplicantOrtho-Engineering Products Co.
Decision Date1985-11-15
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SONGER TITANIUM SPINE-L-ROD is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Engineering Products Co.. It received FDA 510(k) clearance on 1985-11-15 under 510(k) number K854313. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONGER TITANIUM SPINE-L-ROD?

SONGER TITANIUM SPINE-L-ROD is a medical device that received FDA 510(k) clearance on 1985-11-15. The listed applicant is Ortho-Engineering Products Co.. The 510(k) number is K854313.

When did SONGER TITANIUM SPINE-L-ROD receive FDA 510(k) clearance?

SONGER TITANIUM SPINE-L-ROD received FDA 510(k) clearance on 1985-11-15, under 510(k) number K854313.

Who is the listed applicant for SONGER TITANIUM SPINE-L-ROD?

The FDA 510(k) record lists Ortho-Engineering Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONGER TITANIUM SPINE-L-ROD?

The FDA product code for SONGER TITANIUM SPINE-L-ROD is KWP.

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

Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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.

↑