DEVICE: Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head (00814703017483)

Device Identifier (DI) Information

Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head
3301.00.105
In Commercial Distribution

TOTAL JOINT ORTHOPEDICS, INC.
00814703017483
GS1

1
078416717 *Terms of Use
Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head, +10.5mm head length
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
59688 Femoral head/stem prosthesis adaptor
A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K213580 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: The Klassic HD Hip System should be stored in a clean, dry location at room temperature
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: +10.5 Millimeter
CLOSE

Device Record Status

635de555-f1fa-4b99-bae0-2374de9066a8
December 23, 2021
1
December 15, 2021
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

[?]
+1(801)486-6070
udi@tjoinc.com
CLOSE