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FDA 510(k)

STAPLE, FIXATION BONE; SCREW FIXATION BONE

K-Number: K931155 · 1994-09-01

ApplicantRoseburg SA
Decision Date1994-09-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STAPLE, FIXATION BONE; SCREW FIXATION BONE is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1994-09-01 under 510(k) number K931155. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAPLE, FIXATION BONE; SCREW FIXATION BONE?

STAPLE, FIXATION BONE; SCREW FIXATION BONE is a medical device that received FDA 510(k) clearance on 1994-09-01. The listed applicant is Roseburg SA. The 510(k) number is K931155.

When did STAPLE, FIXATION BONE; SCREW FIXATION BONE receive FDA 510(k) clearance?

STAPLE, FIXATION BONE; SCREW FIXATION BONE received FDA 510(k) clearance on 1994-09-01, under 510(k) number K931155.

Who is the listed applicant for STAPLE, FIXATION BONE; SCREW FIXATION BONE?

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

What is the FDA product code for STAPLE, FIXATION BONE; SCREW FIXATION BONE?

The FDA product code for STAPLE, FIXATION BONE; SCREW FIXATION BONE is HWC. This falls under the Cardiovascular category.

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Other records listing Roseburg SA 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.

K890081CALIUS-ISABEL CANOVAS SUNGLASSESK885275ASSENAT-BLESCHET SUNGLASSESK882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK874317POIRIER KID-ROLLER MANUAL WHEELCHAIRK872714S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY

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Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, 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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