DEVICE: Restoration (07613153073888)

Download: XML | JSON

Device Identifier (DI) Information

Restoration
6260-8-111
6260-8-111
Howmedica Osteonics Corp.
07613153073888
GS1
1
Long 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
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWL Prosthesis, hip, hemi-, femoral, metal
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
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
Device Size Text, specify: Stem Length: 203.0 Millimeter
Device Size Text, specify: Size: 1
Device Size Text, specify: Distal Diameter: 11.0 Millimeter
Device Size Text, specify: Taper Connection: V40™
CLOSE

Device Status

In Commercial Distribution
September 24, 2015

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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE