LapiLock CD-LL-9002
GUDID 00840124506572
YOCO Blade Double
FUSION ORTHOPEDICS, LLC
Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use Surgical saw blade, oscillating, single-use| Primary Device ID | 00840124506572 |
| NIH Device Record Key | 08a25bf5-9bbb-4b2a-8ff8-8ba574062265 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LapiLock |
| Version Model Number | CD-LL-9002 |
| Catalog Number | CD-LL-9002 |
| Company DUNS | 080307067 |
| Company Name | FUSION ORTHOPEDICS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 00840124506572 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202959
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
[00840124506572]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-27 |
| Device Publish Date | 2022-05-19 |
On-Brand Devices [LapiLock]
| 00840124501768 | Cutting Block Joint Seeker |
| 00840124501751 | Cutting Block 5 & 7.5 |
| 00840124501744 | Sagittal Saw 40 mm |
| 00840124501720 | Fenestration Drill 2.0 mm |
| 00840124506039 | Olive Wire Threaded |
| 00840124506091 | Folcrum 4.0 mm |
| 00840124506084 | Folcrum 3.0mm |
| 00840124506077 | Folcrum 2.0mm |
| 00840124506114 | Cutting Block Right |
| 00840124506107 | Cutting Block Left |
| 00840124506381 | Short Driver 3.0 mm |
| 00840124506374 | Olive Wire Short Thread |
| 00840124506367 | Olive Wire Non-Threaded |
| 00840124506350 | Fulcrum 5.0 mm |
| 00840124506343 | Fulcrum Fix |
| 00840124506336 | Fulcrum Fix Long |
| 00840124506411 | Cutting Block Parallel |
| 00840124506497 | Triplanar Correction System Jig Right |
| 00840124501713 | Triplanar Correction System Jig Left |
| 00840124506572 | YOCO Blade Double |
| 00840124506565 | YOCO Single |
| 00840124507029 | MP Olive Wire Non-Threaded |
| 00840124507012 | MP Olive Wire Threaded |
| 00840124507005 | LapiLock Metatarsal Bone Positioner |
| 00840124507371 | YOCO Single Conmed |
| 00840124507364 | YOCO Double Conmed |
| 00840124507081 | YOCO Single Conmed |
| 00840124507074 | YOCO Double Conmed |
| 00840124508972 | Sagittal Saw, 40 mm |
| 00840124510302 | Sagittal Saw Conmed 40mm |
| 00840124510319 | Sagittal Saw Conmed 40mm Sterile |
| 00840124510333 | YOCO Lapidus Single |
| 00840124510326 | YOCO Lapidus Double |
| 00840124511156 | LapiLock Bone Cut Guide Single Slot |
| 00840124506480 | Met Cup Subcutaneous |
| 00840124511361 | LapiLock Instrumentation Kit (No Implants Included) |
Trademark Results [LapiLock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LAPILOCK 97382001 not registered Live/Pending |
Fusion Orthopedics USA, LLC 2022-04-26 |
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