FDA UDI
In Commercial Distribution
🇺🇸 United States
9.5mm CurvaFix Inserter
DI: 10850070500514
·
Model: CIA-002-LP
·
CURVAFIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 9.5mm CurvaFix Inserter
- Primary DI
- 10850070500514
- Version / Model
- CIA-002-LP
- Catalog Number
- CIA-002-LP
- Company Name
- CURVAFIX, INC.
- Labeler DUNS
- 039779098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-22
- Public Version
- 2
- Public Version Date
- 2026-04-06
- Public Version Status
- Update
- Public Device Record Key
- 08b1701e-9071-4716-830f-137349d88337
Device Description
Cannulated inserter instrument securely attaches to the proximal end of the 9.5 mm Implant and provides torque and axial force during implantation or extraction. It also holds the Implant in place during locking to convert from a flexible state to a rigid state. Engages proximal end of Implant to enable unlocking and removal if needed.
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
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12696 | Orthopaedic inorganic implant inserter/extractor, reusable | A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850070500514 | GS1 |
Customer Contacts
- Phone
- 425-276-8800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252019 | 000 |