DEVICE: Trinity Acetabular Hip System (05055343864593)

Device Identifier (DI) Information

Trinity Acetabular Hip System
321.101
In Commercial Distribution
321.101
CORIN LTD
05055343864593
GS1

1
295437313 *Terms of Use
Trinity M7.5 Screw Hole Occluder
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Acetabulum prosthesis hole plug A sterile implantable device designed as a threaded or non-threaded plug intended to fill any hole of the shell component of a two-piece acetabulum prosthesis (shell and liner). It is made of metallic or polymer material, and is screwed or pushed into the hole after the implantation of the shell component.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K093472 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

0231952f-bb03-46ee-bc0a-9ad166aab5ab
July 06, 2018
3
August 17, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+441285659866 2118
rachel.king@coringroup.com
+441285659866 2203
lucinda.gerber@coringroup.com
CLOSE