Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1064017

FEI Number

3000190635

Entity Name

AME INT'L.

City/State/Country

MIAMI, FL, US

Establishment Address

7440 SOUTH WEST 50 TERR., No. 108, MIAMI, FL 33155, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

AME INT'L. (Owner Number: 9036247)

Owner / Operator Contact Address

7440 SOUTH WEST 50 TERR., #108, --, Miami, FL 33155, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102162

PMA Number

N/A

All Registered Proprietary Names

Parcus Graft Fixation System Standard and Large 4.5mm V-LoX Titanium Suture Anchor w/Needles 6.5mm V-LoX Titanium Suture Anchor 5.5mm V-LoX Titanium Suture Anchor w/Needles 5mm V-LoX Titanium Suture Anchor w/Needles 6.5mm V-LoX3 Titanium Suture Anchors 5.5mm V-LoX3 Titanium Suture Anchor 4.5mm V-LoX Titanium Suture Anchor 5mm V-LoX Titanium Suture Anchor 5.5mm V-LoX Titanium Suture Anchor 6.5mm V-LoX Titanium Suture Anchor w/Needles PTU - Cross Bar Assembly Parcus PTK Parcus Traction Unit PTU - Pole Plate Assembly PTU - Support Rod Assembly Draw Tight 3.2mm Single Loaded Draw Tight 3.2mm Double Loaded Draw Tight 1.8mm Single Loaded 2mm MiTi Suture Anchor w/ or w/o Needles 3.5mm MiTi Suture Anchor w/ or w/o Needles 2.5mm MiTi Suture Anchor w/ or w/o Needles 5.5-6.5mm Punch/Tap Threaded Dilator Graft Station Tray ACL Tray 2.6mm Trocar Tip Guide Pin w/ Eyelet 1.1mm Nitinol Guide Wire 2.4mm Drill Tip Guide Pin w/ or w/o Eyelet 2.4mm Passing Guide Wire 1.5mm Nitinol Guide Wire 2.4mm Drill Tip Guide Pin w/ Q-Eye Suture Passer Series 3 2.8mm Switching Stick Parcus Pin Pack 15 Parcus Pin Pack 11 Parcus Titanium Interference Screw 45 Knotless PEEK CF Push-In Suture Anchor Driver - Sterile 35 Knotless PEEK CF Push-In Suture Anchor Driver - Reusable Parcus Ratchet Chuck Screwdriver 35 Knotless PEEK CF Push-In Suture Anchor Driver - Sterile 3.5mm Hex w/wo Handle PEEK Screwdriver w/wo handle 45 Knotless PEEK CF Push-In Suture Anchor Driver - Reusable Parcus Braid Suture Parcus PEEK CF Interference Screw PEEK CF Interference Screw Driver w/wo Handle Parcus Mallet 4.5mm Twist PEEK Suture Anchors w/ or w/o Needles 6.5mm Twist PEEK Suture Anchors w/ or w/o Needles 5.5mm Twist PEEK Suture Anchors w/ or w/o Needles 5.5mm Triple Twist PEEK Suture Anchors 6.5mm Triple Twist PEEK Suture Anchors 3.2 Awl with Handle 4.1 Awl with Handle 5.5mm Slotted Tendon Harvester 5.5mm Closed Tendon Harvester 4.75mm Closed Tendon Harvester 4.75mm Slotted Tendon Harvester GFS Mini GFS II 4.5mm V-LoX Hybrid PEEK CF Suture Anchor w/ or w/o Needles Series 3 35 Knotless PEEK CF Push-in Suture Anchor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-12-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-12-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-12-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-13
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2013-12-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-12-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-12-11
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-12-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-12-16
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2013-12-13
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-12-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-12-13
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-12-13
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-12-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-12-13
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-12-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-12-16
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-12-16
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2013-12-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-02-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-12-13

Official Correspondent

VICTOR FERNANDEZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AME INT'L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1064017. Last updated year: 2026. Please use registration number 1064017 when referencing this establishment in official correspondence.