Biosteon® IntraLine® 3910-200-080
GUDID 15060155711154
The Biosteon® IntraLine 4.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which wil
BIOCOMPOSITES LTD
Orthopaedic bone screw, bioabsorbable| Primary Device ID | 15060155711154 |
| NIH Device Record Key | 80d91ef3-ef8a-4cc5-8844-6203ff10e6cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biosteon® IntraLine® |
| Version Model Number | 3910-200-080 |
| Catalog Number | 3910-200-080 |
| Company DUNS | 424382307 |
| Company Name | BIOCOMPOSITES LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com | |
| Phone | +441782338580 |
| info@biocomposites.com |
Device Dimensions
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 117 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 47 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15060155711154 [Primary] |
| GS1 | 35060155711158 [Package] Package: Sleeve [5 Units] In Commercial Distribution |
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-06-30 |
Devices Manufactured by BIOCOMPOSITES LTD
| 15060155710492 - Bilok® ST Screw | 2023-09-18 The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phos |
| 15060155710508 - Bilok® ST Screw | 2023-09-18 The Bilok® ST Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phos |
| 15060155710546 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710577 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710584 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710607 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710614 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
| 15060155710621 - Bilok® Screw | 2023-09-18 The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium |
Trademark Results [Biosteon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSTEON 76266609 2648714 Live/Registered |
Biocomposites Ltd 2001-06-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.