Ossera™ AFX Instrumentation
- Primary DI
- 00840097534664
- Company
- Restor3d, Inc.
- Model
- 5740-3840
- Device description
- Ossera AFX™ Trial, Cylinder, 38D x 40H
- Published
- 2025-12-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840097534664 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00840097534664 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| SAI | Ankle Fusion Cage | 2 | Orthopedic | 888.3020 | Y | Ineligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K242356 | 000 | TIDAL Fusion Cage System | Restor3D, Inc. | 2025-03-24 | SAI |
GMDN Terms
| Term | Definition |
|---|
| Surgical implant template, reusable | A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device. |
Device Sizes
No records found.
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
No records found.
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00840097513256 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097513263 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097513270 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097513287 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097515724 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097515731 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097519333 | Ossera™ AFX | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097519340 | Ossera™ AFX | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097519357 | Ossera™ AFX | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097519364 | Ossera™ AFX | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097519371 | Ossera™ AFX | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097519388 | Ossera™ AFX | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097532370 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097532387 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533599 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533612 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533629 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533636 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533643 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533650 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533667 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533674 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533711 | Ossera™ AFX | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533728 | Ossera™ AFX | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097533735 | Ossera™ AFX | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097534367 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097534374 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097534381 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097534398 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |
| 00840097534411 | Ossera™ AFX Instrumentation | Restor3d, Inc. | SAI | 2025-12-18 |