Velora Acetabular System Instrumentation
- Primary DI
- 00840097535463
- Company
- Restor3d, Inc.
- Model
- 6902-H040
- Device description
- Velora Single Use Liner Trial, GRP H (60-62), 40mm, FCL
- Published
- 2025-12-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 080819836
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840097535463 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00840097535463 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | Orthopedic | 888.3358 | Y | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K252067 | 000 | Velora Acetabular System | Restor3D, Inc. | 2025-12-05 | LPH |
GMDN Terms
| Term | Definition |
|---|
| Acetabulum prosthesis trial, prefabricated, single-use | A copy of a final acetabular cup prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer materials and may be designed in the form of cages, shells or inserts. This is a single-use device. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
No records found.
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