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)

PRIMAL OK INTERSPINOUS FUSION SYSTEM

K-Number: K100354 · 2010-08-17

ApplicantOsteomed LP
Decision Date2010-08-17
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRIMAL OK INTERSPINOUS FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2010-08-17 under 510(k) number K100354. 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 PRIMAL OK INTERSPINOUS FUSION SYSTEM?

PRIMAL OK INTERSPINOUS FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-17. The listed applicant is Osteomed LP. The 510(k) number is K100354.

When did PRIMAL OK INTERSPINOUS FUSION SYSTEM receive FDA 510(k) clearance?

PRIMAL OK INTERSPINOUS FUSION SYSTEM received FDA 510(k) clearance on 2010-08-17, under 510(k) number K100354.

Who is the listed applicant for PRIMAL OK INTERSPINOUS FUSION SYSTEM?

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

What is the FDA product code for PRIMAL OK INTERSPINOUS FUSION SYSTEM?

The FDA product code for PRIMAL OK INTERSPINOUS FUSION SYSTEM 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 Osteomed LP 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.

K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEMK123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTORK123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEMK120015OSTEOMED WRIST PLATING SYSTEMK111419OSTEOMED HAND FUSION SYSTEMK111176OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM

View all 27 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.

↑