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)

SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST

K-Number: K921948 · 1993-06-22

ApplicantSynthes (Usa)
Decision Date1993-06-22
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1993-06-22 under 510(k) number K921948. 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 SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST?

SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Synthes (Usa). The 510(k) number is K921948.

When did SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST receive FDA 510(k) clearance?

SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST received FDA 510(k) clearance on 1993-06-22, under 510(k) number K921948.

Who is the listed applicant for SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST?

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

What is the FDA product code for SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST?

The FDA product code for SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST 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 Synthes (Usa) 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

View all 409 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.

↑