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Data / Medical devices / United States / Ame Int'l.

Ame Int'l.: FDA-registered device maker in Miami, FL, United States, 17 510(k) clearances

Ame Int'l. is registered with the FDA (registration 1064017) in Miami, FL, United States. It lists 21 device types. The FDA files 17 510(k) clearances under its listings, the newest dated November 18, 2016. Registered through 2026. 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.

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FDA registration number
1064017
FEI number
3000190635
Address
7440 SOUTH WEST 50 TERR., No. 108, Miami, FL, United States, 33155
Owner or operator
AME INT'L. (9036247)
Roles
Repackager or relabeler
First device listed
May 6, 2008
Registered through
2026
Brand names listed
1.1mm Nitinol Guide Wire, 1.5mm Nitinol Guide Wire, 2.4mm Drill Tip Guide Pin w/ Q-Eye, 2.4mm Drill Tip Guide Pin w/ or w/o Eyelet, 2.4mm Passing Guide Wire, 2.5mm MiTi Suture Anchor w/ or w/o Needles, 2.6mm Trocar Tip Guide Pin w/ Eyelet, 2.8mm Switching Stick and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Repackager or relabeleraccessdata.fda.gov
AwlHWJ1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Component, Traction, Non-InvasiveKQZ1Repackager or relabeleraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Repackager or relabeleraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
PasserHWQ1Repackager or relabeleraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Repackager or relabeleraccessdata.fda.gov
Screw, Fixation, BoneHWC2Repackager or relabeleraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Stripper, SurgicalHRT1Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyesterGAS2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Repackager or relabeleraccessdata.fda.gov
Tap, BoneHWX1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.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
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
May 10, 2010K100006HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEEDGATSubstantially EquivalentRiverpoint Medicalaccessdata.fda.gov
March 18, 2010K094028CP-FIBER (ORTHOFIBER)GATSubstantially EquivalentCp Medicalaccessdata.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
August 6, 1999K992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESHRXSubstantially EquivalentFiber Imaging Technologies, Inc.accessdata.fda.gov

Compare with other makers

Updated November 18, 2016. 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.