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FDA 510(k)

NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR

K-Number: K021342 · 2002-08-01

ApplicantOsteomedics, Inc.
Decision Date2002-08-01
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Osteomedics, Inc.. It received FDA 510(k) clearance on 2002-08-01 under 510(k) number K021342. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR?

NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR is a medical device that received FDA 510(k) clearance on 2002-08-01. The listed applicant is Osteomedics, Inc.. The 510(k) number is K021342.

When did NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR receive FDA 510(k) clearance?

NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR received FDA 510(k) clearance on 2002-08-01, under 510(k) number K021342.

Who is the listed applicant for NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR?

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

What is the FDA product code for NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR?

The FDA product code for NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR is JEY.

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Other records listing Osteomedics, 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.

K022035OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORBK022324NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEMK022231NORMED DISTAL RADIUS RECONSTRUCTION SYSTEMK022230NORMED MINI EXTERNAL FIXATOR SYSTEMK022325NORMED TITANIUM OSTEOTOMY PLATING SYSTEMK022323NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM

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Related Devices (Code: JEY)

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 SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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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