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FDA 510(k)

FLEXIBLE FASCICULATED BONE PLATE

K-Number: K870041 · 1987-07-17

ApplicantThe Deca Co.
Decision Date1987-07-17
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE FASCICULATED BONE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is The Deca Co.. It received FDA 510(k) clearance on 1987-07-17 under 510(k) number K870041. 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 FLEXIBLE FASCICULATED BONE PLATE?

FLEXIBLE FASCICULATED BONE PLATE is a medical device that received FDA 510(k) clearance on 1987-07-17. The listed applicant is The Deca Co.. The 510(k) number is K870041.

When did FLEXIBLE FASCICULATED BONE PLATE receive FDA 510(k) clearance?

FLEXIBLE FASCICULATED BONE PLATE received FDA 510(k) clearance on 1987-07-17, under 510(k) number K870041.

Who is the listed applicant for FLEXIBLE FASCICULATED BONE PLATE?

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

What is the FDA product code for FLEXIBLE FASCICULATED BONE PLATE?

The FDA product code for FLEXIBLE FASCICULATED BONE PLATE is JEY.

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Other records listing The Deca Co. 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.

K870040INTRAMEDULLARY NAILK863239FASCICULATED BOAT RODK863215FASCICULATED I RODK863271FASCICULATED S RODK861183INTRAMEDULLARY RODK854227FASCILULATED NAIL

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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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