Equinoxe®
- Primary DI
- 10885862625656
- Company
- Exactech, Inc.
- Model
- 320-55-07
- Catalog number
- 320-55-07
- Device description
- Central Screw Baseplate
- Published
- 2024-08-13
- 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
- 157565946
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- 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 |
|---|
| 10885862625656 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 10885862625656 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 2 | Orthopedic | 888.3660 | Y | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K233482 | 000 | Equinoxe® Central Screw Baseplate System | Exactech, Inc. | 2024-07-18 | PHX |
GMDN Terms
| Term | Definition |
|---|
| Reverse shoulder prosthesis base plate | A sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere). |
Device Sizes
| Type | Value | Text |
|---|
| Device Size Text, specify | 0 | 8/10 Degree |
| Device Size Text, specify | 0 | Left |
| Device Size Text, specify | 0 | Posterior/Superior Augment |
Storage And Handling
No records found.
Contacts
No records found.
Other Devices From This Company
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