LIGAFIX COM3008020
GUDID 03760154008556
Absorbable interference screw
S.B.M
Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw| Primary Device ID | 03760154008556 |
| NIH Device Record Key | ca5464e1-51c5-440f-992f-f502a586475f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LIGAFIX |
| Version Model Number | LIGAFIX 30 round head |
| Catalog Number | COM3008020 |
| Company DUNS | 772462123 |
| Company Name | S.B.M |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
Device Dimensions
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 8 Millimeter |
Operating and Storage Conditions
| 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 | 03760154008556 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-28 |
| Device Publish Date | 2023-12-20 |
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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