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FDA 510(k)

BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY

K-Number: K901095 · 1990-04-27

ApplicantGrimm & Norton
Decision Date1990-04-27
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Grimm & Norton. It received FDA 510(k) clearance on 1990-04-27 under 510(k) number K901095. 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 BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY?

BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY is a medical device that received FDA 510(k) clearance on 1990-04-27. The listed applicant is Grimm & Norton. The 510(k) number is K901095.

When did BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY receive FDA 510(k) clearance?

BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY received FDA 510(k) clearance on 1990-04-27, under 510(k) number K901095.

Who is the listed applicant for BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY?

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

What is the FDA product code for BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY?

The FDA product code for BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY is JEY.

Related Clinical Trials

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.

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Other records listing Grimm & Norton 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.

K901094HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERYK872595HOLDING ROD, SURGICAL FORCEPS, WEINSTEIN,12X2 3/4

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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