WM WORLD MEDICAL IMPORTACAO E EXPORTACAO LTDA.

FDA Device Registration & Listing · Rio de Janeiro, BR · Registration 3013086329

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013086329
FEI Number
3013086329
Entity Name
WM WORLD MEDICAL IMPORTACAO E EXPORTACAO LTDA.
City/State/Country
Rio de Janeiro, BR
Establishment Address
Rua do Rezende, 189, Centro, Rio de Janeiro 20231-0910, BR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ZimmerBiomet Americas DFE (Owner Number: 10056779)
Owner / Operator Contact Address
1800 W Center St., Warsaw, IN 46580, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

ARTHROTEK INTERFERENCE SCREW ANA0TOMICAL SHOULDER TM COMBINED SYSTEM ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM Zimmer Plates and Screws (ZPS), Forte Screws ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM Non-Locking Screw

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-03-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-24
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-03-24
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2023-03-24
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-03-24
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-12-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2022-12-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-03-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-24
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-03-24
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-03-24
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2023-03-24
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-03-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

Stephanie Lynch Business: Zimmer Biomet Email: stephanie.lynch@zimmerbiomet.com Phone: (715) 9289253

Related Public Records

Same Entity

ZimmerBiomet Americas DFE
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006809628 Biomet Mexico Mexico City Ciudad de Mexico, MX
3014315560 Zimmer Biomet Centroamerica SA san jose, CR
3014302784 BIOMET CHILE S.A. Santiago de Chile Region Metropolitana, CL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K203334 Acuitive Technologies, Inc. The Citrefix Knotless Suture Anchor 2021-02-05
K243467 Osteonic Co., Ltd. Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) 2024-12-03
K213415 OSSIO , Ltd. OSSIOfiber Suture Anchor 2022-03-28
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27

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 3013086329. Last updated year: 2026. Please use registration number 3013086329 when referencing this establishment in official correspondence.
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