FDA UDI
In Commercial Distribution
🇺🇸 United States
DJO SURGICAL
DI: 00888912116992
·
Model: 370-25-506
·
Encore Medical, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DJO SURGICAL
- Primary DI
- 00888912116992
- Version / Model
- 370-25-506
- Company Name
- Encore Medical, L.P.
- Labeler DUNS
- 154074504
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1c8a23d1-6ba2-4e05-a9ab-6b7c1825f176
Device Description
FOUNDATION® KNEE SYSTEM Constrained Revision PS Insert 25mm CM
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33665 | Posterior-stabilized total knee prosthesis | A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative joint [total knee arthroplasty (TKA)] or for prosthesis revision; it is implanted when the posterior cruciate ligament is sacrificed and uses a “cam and post†mechanism to replace the stabilizing function of the ligament. It includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implanted with or without bone cement and is often used in cases where bone stock and mediolateral stability are good in the face of severe deformities or ligament degeneration. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888912116992 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K933539 | 000 |