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Data / Medical devices / United States / Parcus Medical, L.L.C.

Parcus Medical, L.L.C.: FDA-registered device maker in Sarasota, FL, United States, 31 510(k) clearances

Parcus Medical, L.L.C. is registered with the FDA (registration 3007319107) in Sarasota, FL, United States. It lists 19 device types. The FDA files 31 510(k) clearances under its listings, the newest dated September 18, 2023. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Parcus Medical, L.L.C.
FDA registration number
3007319107
Address
6423 Parkland Dr, Sarasota, FL, United States, 34243
Owner or operator
Medacta International SA (10024526)
Roles
Manufacturer, Specification developer
First device listed
February 11, 2008
Registered through
2027
Brand names listed
ATLAS, AcTiFlip , GFS Ultimate Hip, ActiFlip, Arthroscopic Instruments, Awl, Bone Tap, Bone screw starter, DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Component, Traction, Non-InvasiveKQZ1Manufactureraccessdata.fda.gov
ElevatorHTE1Manufactureraccessdata.fda.gov
ExtractorHWB1Manufactureraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
PasserHWQ1Manufacturer, Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Starter, Bone ScrewHWD1Manufactureraccessdata.fda.gov
Stripper, SurgicalHRT1Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 18, 2023K232513X-Twist Biocomposite Suture AnchorMAISubstantially EquivalentParcus Medicalaccessdata.fda.gov
July 26, 2022K221502Parcus Synd-EZ SSMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
May 19, 2022K221135X-Twist PEEK Suture AnchorMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
October 6, 2021K212739ActiFlipMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
February 22, 2021K202662Parcus Titanium Interference ScrewsMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
October 28, 2020K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate HipMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
July 23, 2020K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
January 23, 2020K193295Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
January 16, 2020K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
November 22, 2019K192964Parcus Synd-EZ SSMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
November 2, 2019K192824Parcus Knotless AP Suture AnchorsMAISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
October 9, 2019K191783Parcus Synd-EZ TiMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
April 24, 2019K190375Parcus ATLASMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
March 15, 2019K183501Parcus Twist AP Suture AnchorsMAISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
February 7, 2019K183331Parcus GFS BTBMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
June 2, 2017K170877Parcus SLiK Fix ScrewMBISubstantially EquivalentParcus Medicalaccessdata.fda.gov
March 30, 2017K170327Parcus SLiK AnchorsMBISubstantially EquivalentParcus Medicalaccessdata.fda.gov
November 18, 2016K162198GFS UltimateMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
November 20, 2015K152711Parcus GFS NakedMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
February 4, 2014K133757GFS II STANDARD, GFS II LARGE, GFS MIMIMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
February 5, 2013K122805PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHORMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
April 20, 2012K120942PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANCMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
January 17, 2012K113730PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORSMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
July 28, 2011K111000PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHORHWCSubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
November 15, 2010K102326PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHORHWCSubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
November 10, 2010K102162PARCUS PEEK CF PUSH-IN SUTURE ANCHORHWCSubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
September 30, 2009K091094PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264MBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
September 30, 2009K091093PARCUS PPEK CF INTERFERENCE SCREWHWCSubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
June 30, 2009K090923PARCUS GRAFT FIXATION SYSTEMMBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
March 6, 2009K090075PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258MBISubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov
March 6, 2009K083619PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020HWCSubstantially EquivalentParcus Medical, LLCaccessdata.fda.gov

Compare with other makers

Updated September 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.