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)

CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM

K-Number: K071138 · 2007-08-15

ApplicantProsurg, Inc.
Decision Date2007-08-15
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K071138. 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 CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM?

CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Prosurg, Inc.. The 510(k) number is K071138.

When did CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM receive FDA 510(k) clearance?

CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071138.

Who is the listed applicant for CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM?

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

What is the FDA product code for CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM?

The FDA product code for CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM 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 Prosurg, Inc. 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.

K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaK152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)K152619Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)K120766ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)K072528ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIESK070737XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES

View all 16 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.

↑