FDA UDI
Not in Commercial Distribution
🇺🇸 United States
APEX Spine System
DI: M824SSM6T20H1
·
Model: SS-M6-T20H
·
SPINECRAFT, LLC
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- APEX Spine System
- Primary DI
- M824SSM6T20H1
- Version / Model
- SS-M6-T20H
- Company Name
- SPINECRAFT, LLC
- Labeler DUNS
- 783908713
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-13
- Public Version
- 2
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 15aaa5f6-3d56-4eee-94a5-79a00c4a96d6
- Distribution End Date
- 2024-09-15
Device Description
T-20 Drive, M6 Set Screw
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | Orthopedic | 888.3060 | 2 |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | Orthopedic | 888.3050 | 2 |
| MNH | Orthosis, spondylolisthesis spinal fixation | Orthopedic | 888.3070 | 2 |
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease | Orthopedic | 888.3070 | 2 |
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65553 | Spinal bone set screw | A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M824SSM6T20H1 | HIBCC |
Customer Contacts
- Phone
- +1(630)920-7300
- [email protected]