DEVICE: INSTRUMENT (07613327211849)
Device Identifier (DI) Information
INSTRUMENT
2102-0470
In Commercial Distribution
2102-0470
Howmedica Osteonics Corp.
2102-0470
In Commercial Distribution
2102-0470
Howmedica Osteonics Corp.
CUTTING EDGE ACETABULAR SPHERICAL REAMER
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? |
|---|---|---|---|---|
| 32848 | Acetabular orthopaedic reamer |
An orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| HWC | Screw, fixation, bone |
| 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 |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Diameter: 70.0 Millimeter |
Device Record Status
3f178b16-fc59-41f4-9a80-80116fdbee47
January 13, 2023
3
September 24, 2016
January 13, 2023
3
September 24, 2016
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
[?]
No Customer Contact currently defined