DEVICE: DJO SURGICAL (00888912100939)

Device Identifier (DI) Information

DJO SURGICAL
933-44-776
In Commercial Distribution

DJO, LLC
00888912100939
GS1

1
081840873 *Terms of Use
LINER 20 DEG HOODED-NEU, MP14, HXE-PLUS, 44mm
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
No
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?
43168 Non-constrained polyethylene acetabular liner
A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OQG Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130365 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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

2b12ed3a-810d-498f-9cb9-35c45470e135
July 06, 2018
3
November 01, 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)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE