Biosteon® Screw 234-010-172
GUDID 15060155711253
The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lactic) Acid and Calcium Phosphate, which will be gradually
BIOCOMPOSITES LTD
Orthopaedic bone screw, bioabsorbable| Primary Device ID | 15060155711253 |
| NIH Device Record Key | a6803748-157e-4444-88c4-e34a2c1e308e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biosteon® Screw |
| Version Model Number | 234-010-172 |
| Catalog Number | 234-010-172 |
| 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 | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 Millimeter |
| Width | 11 Millimeter |
| Length | 28 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 | 15060155711253 [Primary] |
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 | 2015-08-03 |
On-Brand Devices [Biosteon® Screw]
| 15060155711260 | The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact |
| 15060155711253 | The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact |
| 15060155711246 | The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati |
| 15060155711239 | The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati |
| 15060155711222 | The Biosteon® ACL Screw is a cannulated, single-use bone screw made of a resorbable Poly (L-lac |
| 15060155710348 | The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact |
| 15060155710331 | The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact |
| 15060155710324 | The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact |
| 15060155710317 | The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact |
| 15060155710300 | The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact |
| 15060155710294 | The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact |
| 15060155710287 | The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact |
| 15060155710270 | The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati |
| 15060155710263 | The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati |
| 15060155710256 | The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati |
| 15060155710249 | The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati |
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.