JuniOrtho Plating System™
by Orthofix SRL
510(k) K213572
JuniOrtho Plating System is a medical device (FDA Class II; FDA product code HWC, Screw, Fixation, Bone) made by Orthofix SRL, cleared under FDA 510(k) K213572 on 18 Jan 2022, active as of 25 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213572 | Date18 Jan 2022 | StatusActive |
Official records
- FDA 510(k) database K213572
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HWC
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K213572
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| JUNIORTHO PLATING SYSTEM 1 | 5443014 / 1 | 18052469475935 | Outer Diameter 3 mm; Length 14 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5443024 / 1 | 18052469472965 | Outer Diameter 3 mm; Length 24 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5443518 / 1 | 18052469473092 | Outer Diameter 3.5 mm; Length 18 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5443526 / 1 | 18052469473139 | Outer Diameter 3.5 mm; Length 26 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5443540 / 1 | 18052469473207 | Outer Diameter 3.5 mm; Length 40 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5443555 / 1 | 18052469473269 | Outer Diameter 3.5 mm; Length 55 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5444514 / 1 | 18052469473306 | Outer Diameter 4.5 mm; Length 14 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5444538 / 1 | 18052469473429 | Outer Diameter 4.5 mm; Length 38 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5444540 / 1 | 18052469473436 | Outer Diameter 4.5 mm; Length 40 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5444546 / 1 | 18052469473467 | Outer Diameter 4.5 mm; Length 46 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5444565 / 1 | 18052469473511 | Outer Diameter 4.5 mm; Length 65 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5453012 / 1 | 18052469473566 | Outer Diameter 3 mm; Length 12 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5453022 / 1 | 18052469473610 | Outer Diameter 3 mm; Length 22 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5453042 / 1 | 18052469473719 | Outer Diameter 3 mm; Length 42 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5453060 / 1 | 18052469473771 | Outer Diameter 3 mm; Length 60 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5453528 / 1 | 18052469473870 | Outer Diameter 3.5 mm; Length 28 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5453532 / 1 | 18052469473894 | Outer Diameter 3.5 mm; Length 32 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5453538 / 1 | 18052469473924 | Outer Diameter 3.5 mm; Length 38 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5453548 / 1 | 18052469473979 | Outer Diameter 3.5 mm; Length 48 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5455016 / 1 | 18052469474044 | Outer Diameter 5 mm; Length 16 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5455024 / 1 | 18052469474082 | Outer Diameter 5 mm; Length 24 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5455042 / 1 | 18052469474174 | Outer Diameter 5 mm; Length 42 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443026 / 1 | 18052469474419 | Outer Diameter 3 mm; Length 26 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443030 / 1 | 18052469474433 | Outer Diameter 3 mm; Length 30 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443034 / 1 | 18052469474457 | Outer Diameter 3 mm; Length 34 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443510 / 1 | 18052469474495 | Outer Diameter 3.5 mm; Length 10 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443518 / 1 | 18052469474532 | Outer Diameter 3.5 mm; Length 18 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443520 / 1 | 18052469474549 | Outer Diameter 3.5 mm; Length 20 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443536 / 1 | 18052469474624 | Outer Diameter 3.5 mm; Length 36 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443538 / 1 | 18052469474631 | Outer Diameter 3.5 mm; Length 38 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443544 / 1 | 18052469474662 | Outer Diameter 3.5 mm; Length 44 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443548 / 1 | 18052469474686 | Outer Diameter 3.5 mm; Length 48 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443550 / 1 | 18052469474693 | Outer Diameter 3.5 mm; Length 50 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5443570 / 1 | 18052469474730 | Outer Diameter 3.5 mm; Length 70 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5444522 / 1 | 18052469474785 | Outer Diameter 4.5 mm; Length 22 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5444524 / 1 | 18052469474792 | Outer Diameter 4.5 mm; Length 24 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5444530 / 1 | 18052469474822 | Outer Diameter 4.5 mm; Length 30 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5444532 / 1 | 18052469474839 | Outer Diameter 4.5 mm; Length 32 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5444544 / 1 | 18052469474891 | Outer Diameter 4.5 mm; Length 44 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5444575 / 1 | 18052469474976 | Outer Diameter 4.5 mm; Length 75 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5453022 / 1 | 18052469475058 | Outer Diameter 3 mm; Length 22 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5453038 / 1 | 18052469475133 | Outer Diameter 3 mm; Length 38 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5453534 / 1 | 18052469475348 | Outer Diameter 3.5 mm; Length 34 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5453536 / 1 | 18052469475355 | Outer Diameter 3.5 mm; Length 36 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5453542 / 1 | 18052469475386 | Outer Diameter 3.5 mm; Length 42 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5453555 / 1 | 18052469475430 | Outer Diameter 3.5 mm; Length 55 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5455024 / 1 | 18052469475522 | Outer Diameter 5 mm; Length 24 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5455036 / 1 | 18052469475584 | Outer Diameter 5 mm; Length 36 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5455048 / 1 | 18052469475645 | Outer Diameter 5 mm; Length 48 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5455070 / 1 | 18052469475690 | Outer Diameter 5 mm; Length 70 mm | On the market |
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