FDA UDI
In Commercial Distribution
🇺🇸 United States
Synicem 58 Knee Trial FDA
DI: 15060155712328
·
Model: 885418
·
BIOCOMPOSITES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Synicem 58 Knee Trial FDA
- Primary DI
- 15060155712328
- Version / Model
- 885418
- Catalog Number
- 885418
- Company Name
- BIOCOMPOSITES LTD
- Labeler DUNS
- 424382307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-08
- Public Version
- 2
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 5db745ad-ff7e-4d19-91cb-28980b7b8c1f
Device Description
Reusable Knee Trial Spacer allows for the selection of the correct knee spacer to avoid manipulation prior to implantation during a 2-step revision knee arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Knee Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63524 | Knee revision femur/tibia prosthesis trial | A copy of a final knee revision prosthesis, in the form of combined femoral and tibial components, designed to be used before revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060155712328 | GS1 |
Customer Contacts
- Phone
- +441782338580
- [email protected]