DEVICE: APTUS (07630008491482)
Device Identifier (DI) Information
APTUS
A-4700.70
In Commercial Distribution
A-4700.70
Medartis AG
A-4700.70
In Commercial Distribution
A-4700.70
Medartis AG
2.5/2.8 Concave Washer, 5/Pkg
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 61670 | Implantable bone washer |
An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HRS | Plate, fixation, bone |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K051567 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
6804c503-6ea5-47a2-a636-e196ef33591e
September 18, 2023
4
May 12, 2016
September 18, 2023
4
May 12, 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:
07630037804338
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined