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FDA 510(k)

OSTEOMED MODULAR LOCKING FIXATION SYSTEM

K-Number: K080694 · 2008-05-15

ApplicantOsteomed LP
Decision Date2008-05-15
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED MODULAR LOCKING FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K080694. 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 OSTEOMED MODULAR LOCKING FIXATION SYSTEM?

OSTEOMED MODULAR LOCKING FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is Osteomed LP. The 510(k) number is K080694.

When did OSTEOMED MODULAR LOCKING FIXATION SYSTEM receive FDA 510(k) clearance?

OSTEOMED MODULAR LOCKING FIXATION SYSTEM received FDA 510(k) clearance on 2008-05-15, under 510(k) number K080694.

Who is the listed applicant for OSTEOMED MODULAR LOCKING FIXATION SYSTEM?

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

What is the FDA product code for OSTEOMED MODULAR LOCKING FIXATION SYSTEM?

The FDA product code for OSTEOMED MODULAR LOCKING FIXATION SYSTEM is JEY.

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Other records listing Osteomed LP 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.

K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEMK123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTORK123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEMK120015OSTEOMED WRIST PLATING SYSTEMK111419OSTEOMED HAND FUSION SYSTEMK111176OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM

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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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