IntraLock FX-IL-4538
GUDID 00819034026555
Threaded Locking Lag Fastener 4.5mm x 38mm
FUSION ORTHOPEDICS, LLC
Orthopaedic bone screw, non-bioabsorbable, non-sterile| Primary Device ID | 00819034026555 |
| NIH Device Record Key | 59af14d8-fd19-4f8b-bbc3-05cc8bbceca6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IntraLock |
| Version Model Number | FX-IL-4538 |
| Catalog Number | FX-IL-4538 |
| Company DUNS | 080307067 |
| Company Name | FUSION 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819034026555 [Primary] |
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00819034026555]
Moist Heat or Steam Sterilization
[00819034026555]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-29 |
| Device Publish Date | 2020-06-19 |
On-Brand Devices [IntraLock]
| 00819034029617 | Static Set Screw 3.0mm x 16mm |
| 00819034029600 | Static Set Screw 3.0mm x 14mm |
| 00819034028276 | Locking Lag Fastener 4.0mm x 50mm |
| 00819034028269 | Locking Lag Fastener 4.0mm x 45mm |
| 00819034028252 | Locking Lag Fastener 4.0mm x 40mm |
| 00819034028245 | Locking Lag Fastener 4.0mm x 38mm |
| 00819034028238 | Locking Lag Fastener 4.0mm x 36mm |
| 00819034028221 | Locking Lag Fastener 4.0mm x 34mm |
| 00819034028214 | Locking Lag Fastener 4.0mm x 32mm |
| 00819034028207 | Locking Lag Fastener 4.0mm x 30mm |
| 00819034028191 | Locking Lag Fastener 4.0mm x 28mm |
| 00819034028184 | Locking Lag Fastener 4.0mm x 26mm |
| 00819034028177 | Locking Lag Fastener 4.0mm x 24mm |
| 00819034028160 | Locking Lag Fastener 4.0mm x 22mm |
| 00819034026586 | Threaded Locking Lag Fastener 4.5mm x 50mm |
| 00819034026579 | Threaded Locking Lag Fastener 4.5mm x 45mm |
| 00819034026562 | Threaded Locking Lag Fastener 4.5mm x 40mm |
| 00819034026555 | Threaded Locking Lag Fastener 4.5mm x 38mm |
| 00819034026548 | Threaded Locking Lag Fastener 4.5mm x 36mm |
| 00819034026531 | Threaded Locking Lag Fastener 4.5mm x 34mm |
| 00819034026524 | Threaded Locking Lag Fastener 4.5mm x 32mm |
| 00819034026517 | Threaded Locking Lag Fastener 4.5mm x 30mm |
| 00819034026500 | Threaded Locking Lag Fastener 4.5mm x 28mm |
| 00819034026494 | Threaded Locking Lag Fastener 4.5mm x 26mm |
| 00819034026487 | Threaded Locking Lag Fastener 4.5mm x 24mm |
| 00819034026388 | Locking Lag Fastener Solid 4.0mm x 40mm |
| 00819034026371 | Locking Lag Fastener Solid 4.0mm x 38mm |
| 00819034026364 | Locking Lag Fastener Solid 4.0mm x 36mm |
| 00819034026357 | Locking Lag Fastener Solid 4.0mm x 34mm |
| 00819034026340 | Locking Lag Fastener Solid 4.0mm x 32mm |
| 00819034026333 | Locking Lag Fastener Solid 4.0mm x 30mm |
| 00819034026326 | Locking Lag Fastener Solid 4.0mm x 28mm |
| 00819034026319 | Locking Lag Fastener Solid 4.0mm x 26mm |
| 00819034024087 | Threaded Locking Lag Fastener 4.5mm x 22mm |
| 00819034029655 | Static Set Screw 3.0mm x 24mm |
| 00819034029648 | Static Set Screw 3.0mm x 22mm |
| 00819034029631 | Static Set Screw 3.0mm x 20mm |
| 00819034029624 | Static Set Screw 3.0 mm x 18mm |
| 00819034028122 | Locking Lag Fastener 4.5mm x 38mm |
| 00819034028115 | Locking Lag Fastener 4.5mm x 36mm |
| 00819034028108 | Locking Lag Fastener 4.5mm x 34mm |
| 00819034028092 | Locking Lag Fastener 4.5mm x 32mm |
| 00819034028085 | Locking Lag Fastener 4.5mm x 30mm |
| 00819034028078 | Locking Lag Fastener 4.5mm x 28mm |
| 00819034028061 | Locking Lag Fastener 4.5mm x 26mm |
| 00819034028054 | Locking Lag Fastener 4.5mm x 24mm |
| 00819034028047 | Locking Lag Fastener 4.5mm x 22mm |
| 00840124501263 | Locking Lag Fastener 4.0mm x 52mm |
| 00840124501256 | Locking Lag Fastener 4.0mm x 48mm |
| 00840124501249 | Locking Lag Fastener 4.0mm x 46mm |
Trademark Results [IntraLock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTRALOCK 78326077 2916330 Dead/Cancelled |
14 South Networks 2003-11-11 |
 INTRALOCK 75248742 not registered Dead/Abandoned |
IntegrationWare Incorporated 1997-02-27 |
 INTRALOCK 73273296 1186564 Live/Registered |
Sorenson Research Co., Inc. 1980-08-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.