DEVICE: RIGI-FIX Series II (05051693301238)

Device Identifier (DI) Information

RIGI-FIX Series II
Uncemented Hip Stem - Size 3 (134 x 7.5mm)
In Commercial Distribution
HS1455
IMPLANTS INTERNATIONAL LTD
05051693301238
GS1

1
346627222 *Terms of Use
Uncemented Hip Stem for Press Fit Applications - Size 3 (134 x 7.5mm) (12/14 Taper)
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
33581 Coated hip femur prosthesis, modular
A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Room temperature and Dry
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Clinically Relevant Size

[?]
Size Type Text
Length: 134 Millimeter
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Device Record Status

4f0639e8-60cb-48ce-a5d5-a4a295ebe01e
March 29, 2018
2
July 31, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+4401642769080
michael.russon@implantsinternational.com
+4401642769080
mohan.emmanuel@implantsinternational.com
+4401642769080
enquiries@implantsinternational.com
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