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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 a medical device manufactured by Oxford Performance Materials, Inc.. It received FDA 510(k) clearance on 2019-07-03 under approval 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. It is manufactured by Oxford Performance Materials, Inc.. The 510(k) number is K190915.

When was OsteoFab Suture Anchors approved by the FDA?

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

What company makes OsteoFab Suture Anchors?

OsteoFab Suture Anchors is manufactured by Oxford Performance Materials, Inc..

What is the FDA product code for OsteoFab Suture Anchors?

The FDA product code for OsteoFab Suture Anchors is MBI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Oxford Performance Materials, Inc.

K161052OsteoFab Patient Specific Facial Device K180064OsteoFab Patient Specific Cranial Device

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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