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FDA 510(k)

IMTECH FIXATION SYSTEMS

K-Number: K862139 · 1986-07-16

ApplicantImtech, Inc.
Decision Date1986-07-16
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMTECH FIXATION SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Imtech, Inc.. It received FDA 510(k) clearance on 1986-07-16 under 510(k) number K862139. 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 IMTECH FIXATION SYSTEMS?

IMTECH FIXATION SYSTEMS is a medical device that received FDA 510(k) clearance on 1986-07-16. The listed applicant is Imtech, Inc.. The 510(k) number is K862139.

When did IMTECH FIXATION SYSTEMS receive FDA 510(k) clearance?

IMTECH FIXATION SYSTEMS received FDA 510(k) clearance on 1986-07-16, under 510(k) number K862139.

Who is the listed applicant for IMTECH FIXATION SYSTEMS?

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

What is the FDA product code for IMTECH FIXATION SYSTEMS?

The FDA product code for IMTECH FIXATION SYSTEMS is JEY.

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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

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