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)

RESORBABLE CRANIAL CLAMPS

K-Number: K021408 · 2002-07-29

ApplicantSynthes (Usa)
Decision Date2002-07-29
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RESORBABLE CRANIAL CLAMPS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2002-07-29 under 510(k) number K021408. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESORBABLE CRANIAL CLAMPS?

RESORBABLE CRANIAL CLAMPS is a medical device that received FDA 510(k) clearance on 2002-07-29. The listed applicant is Synthes (Usa). The 510(k) number is K021408.

When did RESORBABLE CRANIAL CLAMPS receive FDA 510(k) clearance?

RESORBABLE CRANIAL CLAMPS received FDA 510(k) clearance on 2002-07-29, under 510(k) number K021408.

Who is the listed applicant for RESORBABLE CRANIAL CLAMPS?

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 RESORBABLE CRANIAL CLAMPS?

The FDA product code for RESORBABLE CRANIAL CLAMPS is GXR.

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: GXR)

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.

K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.LK221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLCK181539OSSDSIGN CranioplugOssdsign AB

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.

↑