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FDA 510(k)

K-L-W INTRAORAL DISTRACTOR

K-Number: K991875 · 1999-08-18

ApplicantKLS-Martin L.P.
Decision Date1999-08-18
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K-L-W INTRAORAL DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is KLS-Martin L.P.. It received FDA 510(k) clearance on 1999-08-18 under 510(k) number K991875. 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 K-L-W INTRAORAL DISTRACTOR?

K-L-W INTRAORAL DISTRACTOR is a medical device that received FDA 510(k) clearance on 1999-08-18. The listed applicant is KLS-Martin L.P.. The 510(k) number is K991875.

When did K-L-W INTRAORAL DISTRACTOR receive FDA 510(k) clearance?

K-L-W INTRAORAL DISTRACTOR received FDA 510(k) clearance on 1999-08-18, under 510(k) number K991875.

Who is the listed applicant for K-L-W INTRAORAL DISTRACTOR?

The FDA 510(k) record lists KLS-Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-L-W INTRAORAL DISTRACTOR?

The FDA product code for K-L-W INTRAORAL DISTRACTOR is MQN.

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Other records listing KLS-Martin 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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsK254162KLS Martin Ixos SystemK253660KLS Martin Pure Pectus SystemK250988KLS Martin Pure Pectus SystemK250865KLS Martin IPS Forearm SystemK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

View all 75 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.

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