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)

GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM

K-Number: K983814 · 1999-01-14

ApplicantEfratgo, Ltd. HI Tech Bio-Surgical
Decision Date1999-01-14
Product CodeJDO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Efratgo, Ltd. HI Tech Bio-Surgical. It received FDA 510(k) clearance on 1999-01-14 under 510(k) number K983814. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM?

GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-14. The listed applicant is Efratgo, Ltd. HI Tech Bio-Surgical. The 510(k) number is K983814.

When did GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM receive FDA 510(k) clearance?

GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM received FDA 510(k) clearance on 1999-01-14, under 510(k) number K983814.

Who is the listed applicant for GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM?

The FDA 510(k) record lists Efratgo, Ltd. HI Tech Bio-Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM?

The FDA product code for GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM is JDO.

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 Efratgo, Ltd. HI Tech Bio-Surgical 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.

K083648GOTFRIED PHYSIOLOGICAL HIP (PH) NAILK043233GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL

Related Devices (Code: JDO)

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.

K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric TechnologiesK213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc.K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric TraumaK193029CONQUEST FNSmith & Nephew, Inc.K173826THP Hip Fracture Plating SystemBiomet, Inc.K172785CONQUEST FNSmith & Nephew

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.

↑