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FDA 510(k)

TITAMED ANTWERP SYSTEM

K-Number: K896404 · 1990-04-16

ApplicantOptik
Decision Date1990-04-16
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TITAMED ANTWERP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Optik. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K896404. 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 TITAMED ANTWERP SYSTEM?

TITAMED ANTWERP SYSTEM is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Optik. The 510(k) number is K896404.

When did TITAMED ANTWERP SYSTEM receive FDA 510(k) clearance?

TITAMED ANTWERP SYSTEM received FDA 510(k) clearance on 1990-04-16, under 510(k) number K896404.

Who is the listed applicant for TITAMED ANTWERP SYSTEM?

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

What is the FDA product code for TITAMED ANTWERP SYSTEM?

The FDA product code for TITAMED ANTWERP SYSTEM is JEY.

Related Clinical Trials

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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Other records listing Optik 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.

K933776OPTIK LAPAROSCOPEK926166COAST VIDEO ENDOSCOPIC IMAGING SYSTEMK896589MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERPK894558MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SETK894557LIGHTSCOPE SET

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

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