FDA UDI
In Commercial Distribution
🇺🇸 United States
Coated Revision Stem
DI: B046220811161500
·
Model: 16x150
·
SIGNAL MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Coated Revision Stem
- Primary DI
- B046220811161500
- Version / Model
- 16x150
- Catalog Number
- 22-08-1116150
- Company Name
- SIGNAL MEDICAL CORPORATION
- Labeler DUNS
- 169289308
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a3dd52f8-3e15-41d0-806c-10ecdaebd6c7
Device Description
16x150 Coated Revision Stem
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
- Yes
- 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 |
|---|---|---|---|---|
| 61556 | Sleeve femoral/tibial extension, coated | A sterile implantable device typically designed to be attached to a revision femoral stem, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to make up for bone loss during revision arthroplasty or bone resection. The device is a hollow sleeve made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B046220811161500 | HIBCC |
Customer Contacts
- Phone
- 810-364-7070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100370 | 000 |