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)

ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION

K-Number: K920392 · 1992-12-31

ApplicantAcromed Corp.
Decision Date1992-12-31
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION is the device name listed in this FDA 510(k) record. The listed applicant is Acromed Corp.. It received FDA 510(k) clearance on 1992-12-31 under 510(k) number K920392. 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 ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION?

ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION is a medical device that received FDA 510(k) clearance on 1992-12-31. The listed applicant is Acromed Corp.. The 510(k) number is K920392.

When did ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION receive FDA 510(k) clearance?

ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION received FDA 510(k) clearance on 1992-12-31, under 510(k) number K920392.

Who is the listed applicant for ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION?

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

What is the FDA product code for ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION?

The FDA product code for ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION 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

Other records listing Acromed 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.

K980485ISOLA SPINAL SYSTEMK981714TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEMK981113PEDIATRIC PRCK981274ACROMED TIMX PLATE BASED LOW BACK SYSTEMK980228UNIVERSITY PLATE ANTERIOR SYSTEMK974757KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS

View all 41 devices →

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.

↑