FDA UDI
In Commercial Distribution
🇺🇸 United States
Zavation
DI: 00842166173873
·
Model: 380-5565-C
·
Zavation LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Zavation
- Primary DI
- 00842166173873
- Version / Model
- 380-5565-C
- Company Name
- Zavation LLC
- Labeler DUNS
- 069472800
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-16
- Public Version
- 3
- Public Version Date
- 2024-11-12
- Public Version Status
- Update
- Public Device Record Key
- 824d4142-f52a-4662-94f4-995ac1ed9a75
Device Description
Modular Screw 5.5x65
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 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66945 | Femoral neck fixation plate/sleeve | An implantable, non-bioabsorbable, non-customized sheet of firm material that incorporates a sleeve (commonly known as a barrel) at its proximal end designed to be attached with screws to the proximal femur to treat a femoral neck (trochanteric) fracture. The sleeve is intended to be introduced into the bone to hold a sliding screw (commonly known as a lag or dynamic screw) and/or a deployable-hook pin [not included] that is implanted into the femoral head/neck to compress the fracture. It is available in various sleeve angles/sizes. Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., cortical bone screws), may be included with the plate/sleeve. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842166173873 | GS1 |
Customer Contacts
- Phone
- 601-919-1119
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222614 | 000 |