DEVICE: INSTRUMENT (07613327218367)
Device Identifier (DI) Information
INSTRUMENT
6266-0-140
In Commercial Distribution
6266-0-140
Howmedica Osteonics Corp.
6266-0-140
In Commercial Distribution
6266-0-140
Howmedica Osteonics Corp.
COMMAND INSTRUMENT FEMORAL HEAD IMPACTOR
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? |
|---|---|---|---|---|
| 32856 | Orthopaedic implant impactor, reusable |
A metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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 |
| HWC | Screw, fixation, bone |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| 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 |
|---|
| No Device Sizes |
Device Record Status
d6de4f15-82f8-4a37-b1b2-b0be4194a138
June 26, 2023
5
September 24, 2016
June 26, 2023
5
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