FDA UDI
In Commercial Distribution
🇺🇸 United States
Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®
DI: B648C7252000
·
Model: C725-200
·
CURITEVA, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®
- Primary DI
- B648C7252000
- Version / Model
- C725-200
- Company Name
- CURITEVA, INC.
- Labeler DUNS
- 074575332
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-08
- Public Version
- 1
- Public Version Date
- 2026-01-16
- Public Version Status
- New
- Public Device Record Key
- 85747513-c09f-4643-8fc5-8c00ed9cf292
Device Description
STANDALONE ALIF TRIAL INSERTER
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 |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | 888.3080 | 2 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Orthopedic | 888.3080 | 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 | B648C7252000 | HIBCC |
Customer Contacts
- Phone
- +1 (877) 928-7483
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250845 | 000 |