Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000547811

FEI Number

1000547811

Entity Name

IMPLANTS INTL. LTD.

City/State/Country

THORNABY-ON-TEES Stockton-on-Tees, GB

Establishment Address

71 JAY AVE., TEESSIDE INDUSTRIAL EST., THORNABY-ON-TEES Stockton-on-Tees T517 9LZ, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IMPLANTS INTL. LTD. (Owner Number: 9046526)

Owner / Operator Contact Address

71 JAY AVE., TEESSIDE INDUSTRIAL EST., THORNABY-ON-TEES, GB-NOTA T517 9LZ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Omni-Fix Femoral and Tibial Nail Omni-Fix IM Humeral Nail CL Stem Stability Hip Regi-Fix Hip Rim-Fix Cup Performa C-Fit Hip Cer-Met III Cup Universal Wrist Implant System Ring-Lok BI-POLAR Omni-Fix IM Humeral Nail Peri-articular Forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2008-01-05
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2008-01-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-05
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-01-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-05
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-01-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2008-01-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-05
JWI	Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained	Orthopedic	Class 2	888.3800	2008-01-05
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2014-12-29
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2001-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

George Cipolletti Business: Xtremity Solutions, Inc. Email: george@xtremitysolutionsinc.com Phone: (508) 5746038

Related Public Records

Same Entity

IMPLANTS INTL. LTD.

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
K893928	Buckman Co., Inc.	LEVTECH SMALL BONE PLATE	1989-11-03
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 1000547811. Last updated year: 2026. Please use registration number 1000547811 when referencing this establishment in official correspondence.