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510(k) K944831

Device
INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER
Applicant
INNOVASIVE DEVICES, INC.
510(k) number
K944831
Product code
MBI  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1995-02-01
Date received
1994-09-29
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ERIC BANNON
Address
100-B S. St. Hopkinton MA US 01748 01748

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MBI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.2026-09-17
K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.2026-09-02
K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC2026-09-02
K262677Iconix Knotless TRiverpoint Medical2026-08-27
K262047Grappler Suture Anchor SystemParagon 28, Inc.2026-08-03
K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy2026-07-30
K261770Suture Button Repair SystemSkeletal Dynamics, Inc.2026-07-29
K261632Thunderbolt SystemResponsive Arthroscopy, Inc.2026-07-20
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.2026-07-09
K260018Arthrex FiberButtonArthrex, Inc.2026-06-26
K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.2026-05-27
K261363Y-Knotless™ Flex AnchorsCONMED Corporation2026-05-13
K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.2026-05-06
K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC2026-05-01
K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical2026-04-21

Legacy Summary#

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FDA Review#

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