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FDA 510(k)

PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction

K-Number: K202193 · 2020-10-16

ApplicantS.B.M. Sas (Science & Bio Materials)
Decision Date2020-10-16
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction is the device name listed in this FDA 510(k) record. The listed applicant is S.B.M. Sas (Science & Bio Materials). It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K202193. 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 PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction?

PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is S.B.M. Sas (Science & Bio Materials). The 510(k) number is K202193.

When did PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction receive FDA 510(k) clearance?

PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction received FDA 510(k) clearance on 2020-10-16, under 510(k) number K202193.

Who is the listed applicant for PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction?

The FDA 510(k) record lists S.B.M. Sas (Science & Bio Materials) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction?

The FDA product code for PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction is MBI.

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.

NCT02918734Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference ScrewsRECRUITING

Other records listing S.B.M. Sas (Science & Bio Materials) 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.

K223122MENIX®; MENIX® DUO

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

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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