FDA UDI
In Commercial Distribution
🇺🇸 United States
Zyfix Spinal Facet Screw System
DI: M697T07600591
·
Model: T076-0059
·
Xtant Medical Holdings, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Zyfix Spinal Facet Screw System
- Primary DI
- M697T07600591
- Version / Model
- T076-0059
- Company Name
- Xtant Medical Holdings, Inc.
- Labeler DUNS
- 081224143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-28
- Public Version
- 6
- Public Version Date
- 2024-12-06
- Public Version Status
- Update
- Public Device Record Key
- 8b10d5d9-13f9-4d4e-a0c9-825695c09f7e
Device Description
ACCESS SLEEVE ASSY, SHORT
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 |
|---|---|---|---|---|
| MRW | SYSTEM, FACET SCREW SPINAL DEVICE | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47831 | Orthopaedic implantation sleeve, reusable | A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | M697T07600590 | HIBCC | ||||
| Primary | M697T07600591 | HIBCC |
Customer Contacts
- Phone
- +1(888)886-9354
- [email protected]