DEVICE: INSTRUMENT (07613327207965)
Device Identifier (DI) Information
INSTRUMENT
1020-1600
In Commercial Distribution
1020-1600
Howmedica Osteonics Corp.
1020-1600
In Commercial Distribution
1020-1600
Howmedica Osteonics Corp.
ACCOLADE STEM INSERTER/EXTRACTOR
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? |
|---|---|---|---|---|
| 12696 | Orthopaedic implant inserter/extractor, reusable |
A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
| HWC | Screw, fixation, bone |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
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
e08cd0df-5d16-485e-9d1d-91cc85cd6764
January 05, 2023
6
September 24, 2016
January 05, 2023
6
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