FDA UDI
In Commercial Distribution
🇺🇸 United States
Axle Interspinous Fusion System
DI: M697X06004631
·
Model: X060-0463
·
Xtant Medical Holdings, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Axle Interspinous Fusion System
- Primary DI
- M697X06004631
- Version / Model
- X060-0463
- Company Name
- Xtant Medical Holdings, Inc.
- Labeler DUNS
- 081224143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-05-26
- Public Version
- 4
- Public Version Date
- 2021-06-03
- Public Version Status
- Update
- Public Device Record Key
- acb0ae40-590b-495d-9a5f-6a8fa072e3bc
Device Description
Trial-Rasp Sleeve Assembly, 14MM
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 |
|---|---|---|---|---|
| HTR | RASP | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47127 | Lumbar interspinous decompression instrument set, reusable | A collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | M697X06004630 | HIBCC | ||||
| Primary | M697X06004631 | HIBCC |
Customer Contacts
- Phone
- +1(937)847-8400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14 | Millimeter |