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FDA 510(k)

ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4

K-Number: K034045 · 2004-03-23

ApplicantOral Osteodistraction, L.P.
Decision Date2004-03-23
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 is the device name listed in this FDA 510(k) record. The listed applicant is Oral Osteodistraction, L.P.. It received FDA 510(k) clearance on 2004-03-23 under 510(k) number K034045. 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 ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4?

ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 is a medical device that received FDA 510(k) clearance on 2004-03-23. The listed applicant is Oral Osteodistraction, L.P.. The 510(k) number is K034045.

When did ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 receive FDA 510(k) clearance?

ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 received FDA 510(k) clearance on 2004-03-23, under 510(k) number K034045.

Who is the listed applicant for ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4?

The FDA 510(k) record lists Oral Osteodistraction, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4?

The FDA product code for ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 is MQN.

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Other records listing Oral Osteodistraction, L.P. 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.

K042278ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)K014001DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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