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FDA 510(k)

OSSTAPLE, MAXILLOFACIAL

K-Number: K023486 · 2002-10-31

ApplicantBiomedical Enterprises, Inc.
Decision Date2002-10-31
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSTAPLE, MAXILLOFACIAL is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Enterprises, Inc.. It received FDA 510(k) clearance on 2002-10-31 under 510(k) number K023486. 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 OSSTAPLE, MAXILLOFACIAL?

OSSTAPLE, MAXILLOFACIAL is a medical device that received FDA 510(k) clearance on 2002-10-31. The listed applicant is Biomedical Enterprises, Inc.. The 510(k) number is K023486.

When did OSSTAPLE, MAXILLOFACIAL receive FDA 510(k) clearance?

OSSTAPLE, MAXILLOFACIAL received FDA 510(k) clearance on 2002-10-31, under 510(k) number K023486.

Who is the listed applicant for OSSTAPLE, MAXILLOFACIAL?

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

What is the FDA product code for OSSTAPLE, MAXILLOFACIAL?

The FDA product code for OSSTAPLE, MAXILLOFACIAL is JEY.

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Other records listing Biomedical Enterprises, 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.

K153573ConvergeK124022SPEED SHIFTK061385OSSTAPLE, OSSPLATE, OSSFORCEK023488OSSTAPLE, CRANIOFACIAL

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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