FDA UDI
In Commercial Distribution
🇺🇸 United States
SiNAPTIC Osteotomy Wedge System
DI: G817S101181806
·
Model: Evans Wedge - Rev. 1
·
SINTX Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SiNAPTIC Osteotomy Wedge System
- Primary DI
- G817S101181806
- Version / Model
- Evans Wedge - Rev. 1
- Catalog Number
- S-101-181806
- Company Name
- SINTX Technologies, Inc.
- Labeler DUNS
- 028629553
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-06
- Public Version
- 1
- Public Version Date
- 2026-04-14
- Public Version Status
- New
- Public Device Record Key
- b45d3f06-68da-495b-9909-0ed47373f5f4
Device Description
Evans Wedge, 18W x 18D x 6H
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PLF | Bone Wedge | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61617 | Metallic osteotomy fusion cage, non-customized | A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G817S101181806 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252254 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 18 | Millimeter | |
| Width | 18 | Millimeter | |
| Height | 6 | Millimeter |