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FDA 510(k)

OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB

K-Number: K022035 · 2003-01-17

ApplicantOsteomedics, Inc.
Decision Date2003-01-17
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB is the device name listed in this FDA 510(k) record. The listed applicant is Osteomedics, Inc.. It received FDA 510(k) clearance on 2003-01-17 under 510(k) number K022035. 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 OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB?

OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB is a medical device that received FDA 510(k) clearance on 2003-01-17. The listed applicant is Osteomedics, Inc.. The 510(k) number is K022035.

When did OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB receive FDA 510(k) clearance?

OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB received FDA 510(k) clearance on 2003-01-17, under 510(k) number K022035.

Who is the listed applicant for OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB?

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 OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB?

The FDA product code for OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB is JEY.

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Other records listing Osteomedics, Inc. as applicant

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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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