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FDA 510(k)

MAXILLARY DISTRACTOR

K-Number: K003393 · 2001-01-17

ApplicantSynthes (Usa)
Decision Date2001-01-17
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAXILLARY DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2001-01-17 under 510(k) number K003393. 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 MAXILLARY DISTRACTOR?

MAXILLARY DISTRACTOR is a medical device that received FDA 510(k) clearance on 2001-01-17. The listed applicant is Synthes (Usa). The 510(k) number is K003393.

When did MAXILLARY DISTRACTOR receive FDA 510(k) clearance?

MAXILLARY DISTRACTOR received FDA 510(k) clearance on 2001-01-17, under 510(k) number K003393.

Who is the listed applicant for MAXILLARY DISTRACTOR?

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

What is the FDA product code for MAXILLARY DISTRACTOR?

The FDA product code for MAXILLARY DISTRACTOR is JEY.

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Other records listing Synthes (Usa) 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.

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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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