FDA UDI
In Commercial Distribution
🇺🇸 United States
Bilok® Screw
DI: 15060155710645
·
Model: 160-130T
·
BIOCOMPOSITES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bilok® Screw
- Primary DI
- 15060155710645
- Version / Model
- 160-130T
- Catalog Number
- 160-130T
- Company Name
- BIOCOMPOSITES LTD
- Labeler DUNS
- 424382307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-07
- Public Version
- 3
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 55e810e3-9a74-409a-bce5-280ef2dd1f91
Device Description
The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible.
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
- No
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45039 | Bioabsorbable orthopaedic bone screw | A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060155710645 | GS1 | ||||
| Previous | 50601557106488 | GS1 |
Customer Contacts
- Phone
- +441782338580
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 10 | Millimeter | |
| Length | 30 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 45 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 113 Degrees Fahrenheit