FDA.reportPublic FDA data

GFS

Primary DI
M685101710
Brand
GFS
Company
PARCUS MEDICAL LLC
Model
10171
Catalog number
10171
Device description
Large Graft Fixation System, 45 mm Suture Loop
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K090923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090923000PARCUS GRAFT FIXATION SYSTEMParcus Medical, LLC2009-06-30MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M685101710PrimaryHIBCC0

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)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
941-755-7965CustomerService@ParcusMedical.com

Regulatory Flags#

DUNS number
859961950
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816342022033Graft Fixation System200422025-09-16
00816342022040Graft Fixation System200492025-09-16
00816342022057Graft Fixation System200532025-09-16
00816342022064Graft Fixation System200542025-09-16
00816342022071Graft Fixation System200552025-09-16
00816342022088Graft Fixation System200562025-09-16
00816342022095Graft Fixation System200592025-09-16
00816342022101Graft Fixation System200602025-09-16
00816342023887Graft Fixation System200462025-09-16
00816342023900Graft Fixation System200502025-09-16
00816342023955Graft Fixation System20042S2025-09-16
00816342024204Graft Fixation System20049S2025-09-16
00816342024211Graft Fixation System20035S2025-09-16
00816342024228Graft Fixation System20055S2025-09-16
00816342024235Graft Fixation System20054S2025-09-16
00816342024242Graft Fixation System20059S2025-09-16
00816342024259Graft Fixation System20053S2025-09-16
00816342024266Graft Fixation System20056S2025-09-16
00816342024273Graft Fixation System20032S2025-09-16
00816342024280Graft Fixation System20034S2025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810155331412Tigon MedicalTigon Medical LLCMBI2026-07-09
00850029805106Tigon MedicalTigon Medical LLCMBI2026-06-26
07901125601130GMReis Suture AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDAMBI2026-06-25
09353903030201Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-06-24
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918613ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918620ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918637ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
08720629959573SINEFIXBaat Medical Products B.V.MBI2026-04-01
08721515510151SINEFIXBaat Medical Products B.V.MBI2026-04-01
08101755018820HerculesIn2Bones USA, LLCMBI2026-03-30
08437019739744QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
08437019739751QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
08437019739768QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14
00888867465220Arthrex®ARTHREX, INC.MBI2025-06-23
00888867465237Arthrex®ARTHREX, INC.MBI2025-06-23
00888867465244Arthrex®ARTHREX, INC.MBI2025-06-23
00888867501324Arthrex®ARTHREX, INC.MBI2025-06-23
00888867501331Arthrex®ARTHREX, INC.MBI2025-06-23
07613327661989KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327661996KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662009KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662023KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662054ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
08437019739867WasherCap™ Fixation System 11mmABANZA TECNOMED SL.MBI2025-03-10
08437019739898WasherCap Mini Fixation system 3.5mmABANZA TECNOMED SL.MBI2025-02-25
08437019739904WasherCap Mini Fixation system 4.5mmABANZA TECNOMED SL.MBI2025-02-25
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2024-09-19
10818674027097FiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire®T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2023-09-27
10818674027103FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 FiberWireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2023-09-27