PolyLock
GUDID 00840124509757
MiniLock HD (2.5mm x 12mm)
FUSION ORTHOPEDICS, LLC
Implantable orthopaedic fixation device connection screw| Primary Device ID | 00840124509757 |
| NIH Device Record Key | 870c8cd0-4d60-42d6-abdd-8264d1973897 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PolyLock |
| Version Model Number | ML-HD-2512 |
| 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 | 00840124509757 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211843
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
[00840124509757]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-28 |
| Device Publish Date | 2024-05-20 |
On-Brand Devices [PolyLock]
| 00840124501003 | Locking Screw SB 2.0mm x 30mm |
| 00840124500990 | Locking Screw SB 2.0mm x 28mm |
| 00840124500983 | Locking Screw SB 2.0mm x 26mm |
| 00840124500976 | Locking Screw SB 2.0mm x 24mm |
| 00840124500242 | Non-Locking Screw SB 2.0mm x 22mm |
| 00840124500235 | Non-Locking Screw SB 2.0mm x 20mm |
| 00840124500228 | Non-Locking Screw SB 2.0mm x 18mm |
| 00840124500211 | Non-Locking Screw SB 2.0mm x 16mm |
| 00840124500204 | Non-Locking Screw SB 2.0mm x 14mm |
| 00840124500198 | Non-Locking Screw SB 2.0mm x 12mm |
| 00840124500181 | Non-Locking Screw SB 2.0mm x 10mm |
| 00840124500174 | Non-Locking Screw SB 2.0mm x 8mm |
| 00840124500167 | Locking Screw SB 2.0mm x 22mm |
| 00840124500150 | Locking Screw SB 2.0mm x 20mm |
| 00840124500143 | Locking Screw SB 2.0mm x 18mm |
| 00840124500136 | Locking Screw SB 2.0mm x 16mm |
| 00840124500129 | Locking Screw SB 2.0mm x 14mm |
| 00840124500112 | Locking Screw SB 2.0mm x 12mm |
| 00840124500105 | Locking Screw SB 2.0mm x 10mm |
| 00840124500099 | Locking Screw SB 2.0mm x 8mm |
| 00840124500082 | T-Plate SB 8 Hole |
| 00840124500075 | T-Plate SB 7 Hole |
| 00840124500068 | T-Plate SB 6 Hole |
| 00840124500051 | T-Plate SB 5 Hole |
| 00840124500044 | Straight Plate SB 8 Hole |
| 00840124500037 | Straight Plate SB 6 Hole |
| 00840124500020 | Straight Plate SB 5 Hole |
| 00840124500013 | Straight Plate SB 4 Hole Static |
| 00840124500006 | Straight Plate SB 3 Hole |
| 00819034029990 | Straight Plate SB 2 Hole Static |
| 00819034029983 | Straight Plate SB 2 Hole |
| 00819034029976 | Hook Plate SB Right |
| 00819034029969 | Hook Plate SB Left |
| 00819034029952 | Jones Fracture Plate SB Right |
| 00819034029945 | Jones Fracture Plate SB Left |
| 00819034029938 | Evans Plate SB 12mm |
| 00819034029921 | Evans Plate SB 10mm |
| 00819034029914 | Evans Plate SB 8mm |
| 00819034029907 | Evans Plate SB 6mm |
| 00819034029891 | Evans Plate SB Neutral |
| 00819034029884 | Cotton Plate SB 8mm |
| 00819034029877 | Cotton Plate SB 6mm |
| 00819034029860 | Cotton Plate SB 4mm |
| 00819034029853 | Cotton Plate SB Neutral |
| 00840124501102 | Opening Wedge Plate SB 5mm |
| 00819034027040 | Opening Wedge Plate SB 4mm |
| 00819034027033 | Opening Wedge Plate SB 3mm |
| 00840124501041 | Non-Locking Screw SB 2.0mm x 30mm |
| 00840124501034 | Non-Locking Screw SB 2.0mm x 28mm |
| 00840124501027 | Non-Locking Screw SB 2.0mm x 26mm |
Trademark Results [PolyLock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLYLOCK 77847612 3945328 Live/Registered |
Pave Tech, Inc. 2009-10-13 |
POLYLOCK 77847612 3945328 Live/Registered |
JONES, PAMELA 2009-10-13 |
 POLYLOCK 77081186 not registered Dead/Abandoned |
Pave Tech, Inc. 2007-01-11 |
 POLYLOCK 75664123 not registered Dead/Abandoned |
NELSON INDUSTRIES, INC. 1999-03-16 |
 POLYLOCK 75650387 2444983 Dead/Cancelled |
KREITNGER, BARBARA 1999-02-26 |
 POLYLOCK 75531406 2278058 Live/Registered |
GUPTA, LAXMI C., MR. 1998-08-05 |
 POLYLOCK 74259281 1776529 Dead/Cancelled |
SLT North America, Inc. 1992-03-26 |
 POLYLOCK 73481171 1345574 Dead/Cancelled |
TI FLEXIBLE TUBES LIMITED 1984-05-21 |
 POLYLOCK 72450368 1005007 Live/Registered |
STUPPY FLORAL, INC. 1973-02-28 |
 POLYLOCK 72331112 0906175 Dead/Expired |
FELLOWES MANUFACTURING COMPANY 1969-06-27 |
 POLYLOCK 72137403 0741722 Dead/Expired |
THERACHEMIE CHEMISCH THERAPEUTISCHE GESELLSCHAFT MBH 1962-02-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.