Polymer Corporation

FDA Device Registration & Listing · Middletown, CT, US · Registration 3000196378

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
3000196378
FEI Number
3000196378
Entity Name
Polymer Corporation
City/State/Country
Middletown, CT, US
Establishment Address
35 Industrial Park Pl, Middletown, CT 06457, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Polymer Corporation (Owner Number: 10087484)
Owner / Operator Contact Address
35 Industrial Park Place, Middletown, CT 06457, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Osteonics Universal Distal Cement Plug Howmedica Osteonics Restoration HA Hip Stem Osteonics Primary Secur-Fit Plus HIP Stems Osteonics Restoration Monolithic II Slotted HIP Stem Series Osteonics Omnifit HA HIP Stem Series, Osteonics Secur-Fit HA Hip Stem Series, Osteonics Primary Secur-Fit Plus HIP Stems Rejuvenate Monolithic HIP System PT II Distal Cement Spacer Osteonics Omnifit AD-HA Hip Stem Series Omnifit M-HA HIP Stem Series

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2023-03-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2023-03-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2023-03-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2023-03-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2023-03-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-03-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2023-03-05
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2023-03-05
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-03-05
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-03-05
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2023-03-05
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-03-05
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2023-03-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-03-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2023-03-05
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2023-03-05

Official Correspondent

James Ryan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Polymer Corporation
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
K061824 Tornier TORNIER CEMENT RESTRICTOR 2006-09-14
K940328 Orthopaedic Innovations, Inc. PRIME CEMENTED HIP SYSTEM 1995-04-07
K950761 Biomet, Inc. INDEX ACETABULAT COMPONENT 1995-05-02
K972928 Howmedica, Inc. KERBOULL CROSS 1997-11-03
K830313 Biomet, Inc. CFE TOTAL HIP FEMORAL COMPONENT 1983-05-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000196378. Last updated year: 2026. Please use registration number 3000196378 when referencing this establishment in official correspondence.
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