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FDA 510(k)

CHAMPY BONE PLATES & BONE SCREWS

K-Number: K855030 · 1986-01-30

ApplicantAdvanced Biosearch Assn.
Decision Date1986-01-30
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHAMPY BONE PLATES & BONE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biosearch Assn.. It received FDA 510(k) clearance on 1986-01-30 under 510(k) number K855030. 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 CHAMPY BONE PLATES & BONE SCREWS?

CHAMPY BONE PLATES & BONE SCREWS is a medical device that received FDA 510(k) clearance on 1986-01-30. The listed applicant is Advanced Biosearch Assn.. The 510(k) number is K855030.

When did CHAMPY BONE PLATES & BONE SCREWS receive FDA 510(k) clearance?

CHAMPY BONE PLATES & BONE SCREWS received FDA 510(k) clearance on 1986-01-30, under 510(k) number K855030.

Who is the listed applicant for CHAMPY BONE PLATES & BONE SCREWS?

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

What is the FDA product code for CHAMPY BONE PLATES & BONE SCREWS?

The FDA product code for CHAMPY BONE PLATES & BONE SCREWS is JEY.

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Other records listing Advanced Biosearch Assn. 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.

K905514AUTOGENESIS(TM) AUTOMATORK883888CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.K854770MARTIN LAMINAR OSTEOSYNTHESIS SYSTEMK855031MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE PK853916P.M. HIP-FEMORAL PROSTHESISK852839FREEMAN HIP

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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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