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FDA 510(k)

MODUS SAGITTAL SPLIT PLATE

K-Number: K993862 · 1999-12-29

ApplicantThe Straumann Co.
Decision Date1999-12-29
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODUS SAGITTAL SPLIT PLATE is the device name listed in this FDA 510(k) record. The listed applicant is The Straumann Co.. It received FDA 510(k) clearance on 1999-12-29 under 510(k) number K993862. 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 MODUS SAGITTAL SPLIT PLATE?

MODUS SAGITTAL SPLIT PLATE is a medical device that received FDA 510(k) clearance on 1999-12-29. The listed applicant is The Straumann Co.. The 510(k) number is K993862.

When did MODUS SAGITTAL SPLIT PLATE receive FDA 510(k) clearance?

MODUS SAGITTAL SPLIT PLATE received FDA 510(k) clearance on 1999-12-29, under 510(k) number K993862.

Who is the listed applicant for MODUS SAGITTAL SPLIT PLATE?

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

What is the FDA product code for MODUS SAGITTAL SPLIT PLATE?

The FDA product code for MODUS SAGITTAL SPLIT PLATE is JEY.

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Other records listing The Straumann 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.

K041070STRAUMANN TEMPORARY COPINGK040646STRAUMANN GRANULESK040469THE STRAUMANN ORTHO IMPLANT SYSTEMK962023PLASTIC PROTECTION HEALING CAPSK960634TITANIUM HEALING CAPSK955281ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES

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Related Devices (Code: JEY)

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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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