FDA UDI
In Commercial Distribution
🇺🇸 United States
Whistler Modular Pedicle Screw System
DI: 00195860004647
·
Model: WT55-M
·
Evolution Spine LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Whistler Modular Pedicle Screw System
- Primary DI
- 00195860004647
- Version / Model
- WT55-M
- Catalog Number
- WT55-M
- Company Name
- Evolution Spine LLC
- Labeler DUNS
- 116940934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-17
- Public Version
- 3
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- 1064864d-dd0b-4143-be73-d0fc84987ac0
Device Description
Modular 5.5 mm MI Tulip
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| NKB | Thoracolumbosacral pedicle screw system | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66948 | Spinal bone screw head/rod adaptor | A small, implantable, non-bioabsorbable device intended to be attached to the top end of a spinal screw (not included) typically to secure/stabilize a rod and/or connector as part of an internal spinal fixation procedure. Also known as a reduction head or tulip, it is typically U-shaped with threads to receive a set screw and/or has a hole to allow the rod and/or connector to pass through; it may also facilitate a degree of motion. It is available in various lengths and is made of metal (e.g., surgical steel, titanium alloy) and/or synthetic polymer materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195860004647 | GS1 |
Customer Contacts
- Phone
- +1(214)682-8536
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182478 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5.5 | Millimeter |