DEVICE: Instrument (07613327343403)
Device Identifier (DI) Information
Instrument
I-H2085RG40
In Commercial Distribution
I-H2085RG40
Howmedica Osteonics Corp.
I-H2085RG40
In Commercial Distribution
I-H2085RG40
Howmedica Osteonics Corp.
SPECIALTY ACCOLADE II NECK RESECTION GUIDE
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? |
|---|---|---|---|---|
| 13180 | Orthopaedic prosthesis implantation positioning instrument, reusable |
A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| HWC | Screw, fixation, bone |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, 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: Neck Length: 40.0 Millimeter |
Device Record Status
ef86b907-0a8f-41fc-875c-7569d7f26b99
May 03, 2023
3
November 09, 2016
May 03, 2023
3
November 09, 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