FDA UDI
In Commercial Distribution
🇺🇸 United States
Xpress Minimally Invasive Pedicle Screw System
DI: M697C01000821
·
Model: C010-0082
·
Xtant Medical Holdings, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Xpress Minimally Invasive Pedicle Screw System
- Primary DI
- M697C01000821
- Version / Model
- C010-0082
- Company Name
- Xtant Medical Holdings, Inc.
- Labeler DUNS
- 081224143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-05
- Public Version
- 6
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- f29c3fc0-c3ff-4142-ba16-e806110f6d4d
Device Description
Specialty 800mm Blunt End K-wire .048
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| MNI | Orthosis, spinal pedicle fixation | Orthopedic | 888.3070 | 2 |
| MNH | Orthosis, spondylolisthesis spinal fixation | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32854 | Orthopaedic bone pin, non-bioabsorbable | A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | M697C01000820 | HIBCC | ||||
| Primary | M697C01000821 | HIBCC |
Customer Contacts
- Phone
- +1(888)886-9354
- [email protected]