SMALL BONE FIXATION SYSTEM SBFS045
GUDID 00887868072567
1.1mm SS Nail, 1 Locking Device, 1 End Cap, 1 Bending Tool, 1 Awl
Biomet Orthopedics, LLC
Orthopaedic bone pin, non-bioabsorbable| Primary Device ID | 00887868072567 |
| NIH Device Record Key | 4b6dd06a-bd31-4a7b-b257-712fc03112bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMALL BONE FIXATION SYSTEM |
| Version Model Number | SBFS045 |
| Catalog Number | SBFS045 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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 | true |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868072567 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041157
FDA Product Code
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-13 |
| Device Publish Date | 2015-10-21 |
On-Brand Devices [SMALL BONE FIXATION SYSTEM]
| 00887868072574 | 1.6mm SS Nail, 1 Locking Device, 1 End Cap, 1 Bending Tool, 1 Awl |
| 00887868072567 | 1.1mm SS Nail, 1 Locking Device, 1 End Cap, 1 Bending Tool, 1 Awl |
| 00887868445064 | SBFS062 |
| 00887868445057 | SBFS045 |
Trademark Results [SMALL BONE FIXATION SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMALL BONE FIXATION SYSTEM 78784347 not registered Dead/Abandoned |
Small Bone Innovations, LLC 2006-01-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.