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FDA 510(k)

OsteoFab Suture Anchors

K-Number: K190915 · 2019-07-03

ApplicantOxford Performance Materials, Inc.
Decision Date2019-07-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoFab Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Performance Materials, Inc.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K190915. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoFab Suture Anchors?

OsteoFab Suture Anchors is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Oxford Performance Materials, Inc.. The 510(k) number is K190915.

When did OsteoFab Suture Anchors receive FDA 510(k) clearance?

OsteoFab Suture Anchors received FDA 510(k) clearance on 2019-07-03, under 510(k) number K190915.

Who is the listed applicant for OsteoFab Suture Anchors?

The FDA 510(k) record lists Oxford Performance Materials, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoFab Suture Anchors?

The FDA product code for OsteoFab Suture Anchors is MBI.

Other records listing Oxford Performance Materials, Inc. 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.

K180064OsteoFab Patient Specific Cranial DeviceK161052OsteoFab Patient Specific Facial Device

Related Devices (Code: MBI)

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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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