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FDA 510(k)

HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY

K-Number: K901094 · 1990-04-27

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

Device Summary

HEAD FRAME KIT, 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 K901094. 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 HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY?

HEAD FRAME KIT, 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 K901094.

When did HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY receive FDA 510(k) clearance?

HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY received FDA 510(k) clearance on 1990-04-27, under 510(k) number K901094.

Who is the listed applicant for HEAD FRAME KIT, 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 HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY?

The FDA product code for HEAD FRAME KIT, 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.

K901095BI-PHASE SET, 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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