LIGAFIX COM6010035
GUDID 03760154003889
Absorbable interference screw
S.B.M
Orthopaedic bone screw, bioabsorbable| Primary Device ID | 03760154003889 |
| NIH Device Record Key | 85dcf027-10b5-4b93-b1b2-1b84b0ff6835 |
| Commercial Distribution Discontinuation | 2020-01-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | LIGAFIX |
| Version Model Number | LIGAFIX 60 round head |
| Catalog Number | COM6010035 |
| Company DUNS | 772462123 |
| Company Name | S.B.M |
| 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 | true |
| 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 | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us | |
| Phone | 781-369-1782 |
| gboue@s-b-m.us |
Device Dimensions
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 10 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 33 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760154003889 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122228
FDA Product Code
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue |
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 | 2020-01-10 |
| Device Publish Date | 2015-09-23 |
On-Brand Devices [LIGAFIX]
| 03760154008778 | Absorbable interference screw |
| 03760154004527 | Absorbable interference screw |
| 03760154004510 | Absorbable interference screw |
| 03760154004503 | Absorbable interference screw |
| 03760154004442 | Absorbable interference screw |
| 03760154004435 | Absorbable interference screw |
| 03760154004428 | Absorbable interference screw |
| 03760154004411 | Absorbable interference screw |
| 03760154004404 | Absorbable interference screw |
| 03760154004398 | Absorbable interference screw |
| 03760154004381 | Absorbable interference screw |
| 03760154004374 | Absorbable interference screw |
| 03760154004367 | Absorbable interference screw |
| 03760154004350 | Absorbable interference screw |
| 03760154004343 | Absorbable interference screw |
| 03760154004336 | Absorbable interference screw |
| 03760154004329 | Absorbable interference screw |
| 03760154004183 | Absorbable interference screw |
| 03760154003896 | Absorbable interference screw |
| 03760154003889 | Absorbable interference screw |
| 03760154003872 | Absorbable interference screw |
| 03760154003865 | Absorbable interference screw |
| 03760154003858 | Absorbable interference screw |
| 03760154003841 | Absorbable interference screw |
| 03760154003834 | Absorbable interference screw |
| 03760154003827 | Absorbable interference screw |
| 03760154003810 | Absorbable interference screw |
| 03760154003803 | Absorbable interference screw |
| 03760154003797 | Absorbable interference screw |
| 03760154003780 | Absorbable interference screw |
| 03760154003759 | Absorbable interference screw |
| 03760154003742 | Absorbable interference screw |
| 03760154003735 | Absorbable interference screw |
| 03760154003728 | Absorbable interference screw |
| 03760154003711 | Absorbable interference screw |
| 03760154003582 | Absorbable interference screw |
| 03760154003551 | Absorbable interference screw |
| 03760154001311 | Absorbable interference screw |
| 03760154006118 | Rigid guide pin Ø 1.4 mm - L 300 mm to be used with LIGAFIX screwdriver for interference screws |
| 03760154006101 | Rigid guide pin Ø 0.9 mm - L 300 mm to be used with LIGAFIX screwdriver for interference screws |
| 03760154005876 | LIGAFIX L 60 mm - diameter 11 mm cannulated drill bit, longflute, to be used in ACL reconstructi |
| 03760154005821 | LIGAFIX L 60 mm - diameter 10 mm cannulated drill bit, longflute, to be used in ACL reconstructi |
| 03760154005784 | LIGAFIX Green screwdriver to be used with LIGAFIX interference screws of diameter 9, 10 and 11 m |
| 03760154005777 | LIGAFIX L 60 mm - diameter 8 mm cannulated drill bit, longflute, to be used in ACL reconstructio |
| 03760154005760 | LIGAFIX Green screwdriver to be used with LIGAFIX interference screws of diameter 7 & 8 mm in AC |
| 03760154005753 | LIGAFIX L 60 mm - diameter 7 mm cannulated drill bit, longflute, to be used in ACL reconstructio |
| 03760154005746 | LIGAFIX L 60 mm - diameter 6 mm cannulated drill bit, longflute, to be used in ACL reconstructio |
| 03760154005692 | LIGAFIX Graft gauge - half sizes to be used in ACL reconstruction. |
| 03760154005654 | Eyelet pin Ø 2.5 L 400 mm to be used with LIGAFIX interference screws in ACL reconstruction. 1 |
| 03760154004053 | Guide pin introducer for rigid guide pin Ø 0.9 mm to be used with LIGAFIX interference screws i |
Trademark Results [LIGAFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIGAFIX 87630136 not registered Dead/Abandoned |
KATOR, LLC 2017-10-02 |
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