DEVICE: DJO SURGICAL (00888912079662)

Device Identifier (DI) Information

DJO SURGICAL
426-11-060
In Commercial Distribution

Encore Medical, L.P.
00888912079662
GS1

1
154074504 *Terms of Use
CLP® HIP SYSTEM Lateral Offset Stem
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
Press-fit femoral stem prosthesis A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052320 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

8c0e0b7e-cc67-40e8-a24b-5434111d2ecf
July 06, 2018
3
August 07, 2017
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE