DEVICE: Taperloc Complete Hip System (00880304907416)
Device Identifier (DI) Information
Taperloc Complete Hip System
SSI003792
In Commercial Distribution
SSI003792
Biomet Orthopedics, LLC
SSI003792
In Commercial Distribution
SSI003792
Biomet Orthopedics, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
36167 | Orthopaedic broach |
A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate |
MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish |
LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
KWL | Prosthesis, Hip, Hemi-, Femoral, Metal |
JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K101086 | 000 |
K103755 | 000 |
K110400 | 000 |
K120030 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Size 5 |
Device Record Status
c97a7abc-4994-42c3-aa2f-88b6ea126c43
May 30, 2025
4
March 27, 2017
May 30, 2025
4
March 27, 2017
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1(800)348-9500
customerservice@zimmerbiomet.com
customerservice@zimmerbiomet.com