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)

NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR

K-Number: K952847 · 1996-02-06

ApplicantAce Surgical Supply Co., Inc.
Decision Date1996-02-06
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ace Surgical Supply Co., Inc.. It received FDA 510(k) clearance on 1996-02-06 under 510(k) number K952847. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR?

NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR is a medical device that received FDA 510(k) clearance on 1996-02-06. The listed applicant is Ace Surgical Supply Co., Inc.. The 510(k) number is K952847.

When did NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR receive FDA 510(k) clearance?

NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR received FDA 510(k) clearance on 1996-02-06, under 510(k) number K952847.

Who is the listed applicant for NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR?

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

What is the FDA product code for NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR?

The FDA product code for NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR is MQN.

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 Ace Surgical Supply Co., 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.

K093518ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEMK092594ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OXK073343ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XXK080074ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XXK061397ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, MK051381ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE

View all 21 devices →

Related Devices (Code: MQN)

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.

K220050KLS Martin IPS DistractionKLS Martin L.P.K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLCK181504Stryker Pediatric Mandibular Distractor 2StrykerK162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK161470Internal Distraction - SterileKLS Martin L.P.K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMSynthes, 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.

↑