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FDA 510(k)

TITANIUM MESH

K-Number: K903485 · 1991-02-21

ApplicantRuggles Corp.
Decision Date1991-02-21
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TITANIUM MESH is the device name listed in this FDA 510(k) record. The listed applicant is Ruggles Corp.. It received FDA 510(k) clearance on 1991-02-21 under 510(k) number K903485. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITANIUM MESH?

TITANIUM MESH is a medical device that received FDA 510(k) clearance on 1991-02-21. The listed applicant is Ruggles Corp.. The 510(k) number is K903485.

When did TITANIUM MESH receive FDA 510(k) clearance?

TITANIUM MESH received FDA 510(k) clearance on 1991-02-21, under 510(k) number K903485.

Who is the listed applicant for TITANIUM MESH?

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

What is the FDA product code for TITANIUM MESH?

The FDA product code for TITANIUM MESH is GWO.

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 Ruggles Corp. 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.

K902818MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTK902819LAMINECTOMY ROGEURK902850ZEPPELIN INSTRUMENTSK893415TRANS-ORAL DEPTH GAUGE

Related Devices (Code: GWO)

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.

K262874CraniUS PlateCraniUS, LLCK261058CraniUS PlateCraniUS, LLCK250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.

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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