FDA.reportPublic FDA data

SINEFIX

Primary DI
08720629950464
Brand
SINEFIX
Company
Baat Medical Products B.V.
Model
SINEFIX
Catalog number
30001
Device description
Rotator cuff repair device
Published
2023-04-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220966000SINEFIXBAAT Medical Products B.V.2023-03-08MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720629950471PackageGS15Not in Commercial Distribution
08720629950464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720629950471087206299504718720629950471
08720629950464087206299504648720629950464

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Regulatory Flags#

DUNS number
413205480
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720629951256SDS Growing RodSDS Growing RodSDS55ROD2026-03-30
08720629951287SDS Growing RodSDS Growing RodSDS55BUT2026-03-30
08720629951300SDS Growing RodSDS Growing RodSDS55ASB2026-03-30
08720629951324SDS Growing RodSDS Growing RodSDS55PSB2026-03-30
08720629951478SDS Growing RodSDS Growing RodSDSLOCK2026-03-30
08720629951485SDS Growing RodSDS Growing RodSDSCOMPR2026-03-30
08720629958750SDS Growing RodSDS Growing RodSDS55CCL2026-03-30
08720629958767SDS Growing RodSDS Growing RodSDS55S1002026-03-30
08720629958828SDS Growing RodSDS Growing RodSDSTHAN92026-03-30
08720629959573SINEFIXPunch600072026-04-01
08721515510151SINEFIXSINEFIX300012026-04-01
08720629951492SDS Growing RodSDS Growing RodSDSDRIVER2026-03-30
08720629951508SDS Growing RodSDS Growing RodSDSTRAY2026-03-30
08720629958774SDS Growing RodSDS Growing RodSDSFORC2026-03-30
08720629950532SINEFIXRepusher400072023-04-11
08720629950549SINEFIXTray400082023-04-11
08720629959177SINEFIXSINEFIX Easy Grip600022025-07-03
08720246781960Kleiner KG2 systemKG2 Static Parallel 9x24x07x0° 02-911072022-12-14
08720246781977Kleiner KG2 systemKG2 Static Parallel 9x24x08x0°02-911082022-12-14
08720246781984Kleiner KG2 systemKG2 Static Parallel 9x24x09x0°02-911092022-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810146164340RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164357RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164388RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164418RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164449RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164456RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164463RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164500RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164517RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164531RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164562RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164579RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164623RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164654RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164685RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant SystemT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and InserterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462928VersiTILT Button, 2.4x12mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462966VersiTILT Button, 3.1x10.9mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-07-15