DEVICE: REFORM (00815362029671)
Device Identifier (DI) Information
REFORM
10390PS
In Commercial Distribution
39-UP-5525
PRECISION SPINE, INC.
10390PS
In Commercial Distribution
39-UP-5525
PRECISION SPINE, INC.
Reform Uniplanar Screw 5.5 x 25mm (QTY 35)
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? |
|---|---|---|---|---|
| 67309 | Spinal fixation implant/sterilization container set |
A collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K121172 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c86710a2-5667-4820-acd8-654b4c0087d8
November 20, 2025
7
November 17, 2016
November 20, 2025
7
November 17, 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