RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System
OrthoPediatrics, Corp
ORTHOPEDIATRICS, CORP
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006460162 | 3006460162 | ORTHOPEDIATRICS, CORP | 1 | Y | 2026-01-01 | 2850 Frontier Dr Warsaw IN US 46582 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 93935 | 1151759032 | K261345 | Pediatric Nailing Platform Femur | HSB | 2026-09-24 |
| 93935 | 1491551805 | K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | HRS | 2026-04-30 |
| 93935 | 1549977782 | K252600 | Pediatric Plating Platform I Small-Mini | HRS | 2025-10-09 |
| 93935 | 1794010577 | K251362 | PediFlex™ Flexible Nail System | HTY | 2025-06-24 |
| 93935 | 1423980545 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | HSB | 2025-04-01 |
| 93935 | 1694521312 | K243963 | Pediatric Plating Platform Hip | HRS | 2025-04-29 |
| 93935 | 1327828468 | K243798 | Orthex External Fixation System | KTT | 2025-03-07 |
| 93935 | 1106305471 | K241816 | VerteGlide Spinal Growth Guidance System | PGM | 2025-03-14 |
| 93935 | 1902632955 | K233105 | RESPONSE™ Rib and Pelvic System | MDI | 2024-01-20 |
| 93935 | 1736227170 | K231266 | Pediatric Nailing Platform Tibia | HSB | 2023-08-21 |
| 93935 | 1107497227 | K223786 | Orthex External Fixation System | KTT | 2023-02-10 |
| 93935 | 1289236799 | K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | NKB | 2023-03-23 |
| 93935 | 1296235856 | K220809 | Drive Rail System | KTT | 2022-04-08 |
| 93935 | 1556863614 | K220679 | Pediatric Nailing Platform Femur | HSB | 2022-07-20 |
| 93935 | 1585688008 | K203573 | RESPONSE Navigation Instruments | OLO | 2021-02-04 |
| 93935 | 1232318184 | K201838 | PediFlex Flexible Nail System | HTY | 2021-01-29 |
| 93935 | 1576616343 | K200097 | Response BandLoc Spinal Fixation | OWI | 2020-03-16 |
| 93935 | 1369978741 | K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System | NKB | 2020-03-24 |
| 93935 | 1550395593 | K190992 | OrthoPediatrics PediFoot Deformity Corrections System | HRS | 2019-08-06 |
| 93935 | 1747633763 | K190324 | OrthoPediatrics Cannulated Screw System | HWC | 2019-07-05 |
| 93935 | 1694250791 | K190321 | Pediatric Nailing PlatformFemur | HSB | 2019-10-09 |
| 93935 | 1081739391 | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | NKB | 2018-09-18 |
| 93935 | 1459874621 | K172583 | OrthoPediatrics PediNail Intramedullary Platform | HSB | 2018-05-10 |
| 93935 | 1289979989 | K172425 | OrthoPediatrics Wrist Fusion Plate | HRS | 2017-12-06 |
| 93935 | 2063943771 | K171173 | OrthoPediatrics Titanium PediPlates® System | HRS | 2017-08-24 |
| 93935 | 1062019129 | K163487 | Ultima HA Coated Half Pins and Wire | JDW | 2017-02-13 |
| 93935 | 1764824219 | K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws | HRS | 2016-09-27 |
| 93935 | 1528106639 | K161267 | Response BandLoc Spinal Fixation | OWI | 2016-08-11 |
| 93935 | 1693230678 | K160466 | Response 5.5 Spine System | NKB | 2016-03-23 |
| 93935 | 1324243078 | K151881 | X-Fix Line Additions | KTT | 2016-03-24 |
| 93935 | 1382439503 | K150600 | Response 5.5/6.0 Spine System | NKB | 2015-05-22 |
| 93935 | 2033504889 | K140822 | DRIVE RAIL SYSTEM | KTT | 2014-05-29 |
| 93935 | 1032066679 | K140431 | PEDILOC FRAGMENT SYSTEM | HRS | 2014-07-29 |
| 93935 | 1688419899 | K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | JDW | 2014-07-23 |
| 93935 | 1644751185 | K130655 | RESPONSE SPINE SYSTEM | OSH | 2013-05-08 |
| 93935 | 1381938188 | K130217 | ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM | MBI | 2013-06-20 |
| 93935 | 1797323674 | K121250 | OP SPINE SYSTEM | OSH | 2012-06-19 |
| 93935 | 1818430165 | K120291 | OP SPINE SYSTEM | OSH | 2012-04-16 |
| 93935 | 1272467335 | K111086 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM | HRS | 2011-06-17 |
| 93935 | 2060496697 | K110959 | ORTHOPEDIATRICS BLADE PLATE SYSTEM | HRS | 2011-08-05 |
| 93935 | 1849045595 | K100240 | ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM | HRS | 2010-05-17 |
| 93935 | 1538048397 | K090666 | PEDIPLATES | HRS | 2009-04-24 |
| 93935 | 1432905046 | K083726 | PEDINAIL INTRAMEDULLARY NAILING SYSTEM | HSB | 2009-03-11 |
| 93935 | 1305291109 | K083286 | ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM | HRS | 2009-01-30 |
| 93935 | 1310926414 | K082949 | ORTHOPEDIATRICS BONE SCREWS | HWC | 2008-11-25 |
| 93935 | 1214919397 | K082375 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | HTY | 2008-10-17 |
| 93935 | 1554760348 | K081407 | ORTHOPEDIATRICS PEDIPLATES SYSTEM | HRS | 2008-07-22 |
| 93935 | 1154743288 | K081097 | ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM | HTY | 2008-06-03 |
| 93935 | 1918875803 | K073344 | ORTHOPEDIATRICS PLATING SYSTEM | HRS | 2008-02-19 |
| 93935 | 1638811766 | K052196 | VILEX X-FIX | KTT | 2005-11-22 |
| 93935 | 1504553420 | K031050 | PCW PERCUTANEOUS COMPRESSION WIRE | HWC | 2003-07-14 |
| 93935 | 1044242331 | ||||
| 93935 | 1087572316 | ||||
| 93935 | 1102738963 | ||||
| 93935 | 1110763927 | ||||
| 93935 | 1112060154 | ||||
| 93935 | 1162860876 | ||||
| 93935 | 1206273562 | ||||
| 93935 | 1255003439 | ||||
| 93935 | 1268245073 | ||||
| 93935 | 1309593642 | ||||
| 93935 | 1398885534 | ||||
| 93935 | 1409792919 | ||||
| 93935 | 1457773584 | ||||
| 93935 | 1477939944 | ||||
| 93935 | 1567362970 | ||||
| 93935 | 1571157421 | ||||
| 93935 | 1601114817 | ||||
| 93935 | 1614035094 | ||||
| 93935 | 1614884454 | ||||
| 93935 | 1630034620 | ||||
| 93935 | 1631552406 | ||||
| 93935 | 1642404886 | ||||
| 93935 | 1645139017 | ||||
| 93935 | 1656077904 | ||||
| 93935 | 1664569042 | ||||
| 93935 | 1673252472 | ||||
| 93935 | 1692002019 | ||||
| 93935 | 1720371318 | ||||
| 93935 | 1756018047 | ||||
| 93935 | 1771934115 | ||||
| 93935 | 1776871260 | ||||
| 93935 | 1815025034 | ||||
| 93935 | 1824104549 | ||||
| 93935 | 1826486927 | ||||
| 93935 | 1834510164 | ||||
| 93935 | 1847353872 | ||||
| 93935 | 1916073499 | ||||
| 93935 | 2003595485 | ||||
| 93935 | 2018524997 | ||||
| 93935 | 2026819135 | ||||
| 93935 | 2049059644 | ||||
| 93935 | 2060945182 | ||||
| 93935 | 2061693760 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HRS | 15 | 2026-04-30 |
| HSB | 7 | 2026-09-24 |
| KTT | 6 | 2025-03-07 |
| NKB | 5 | 2023-03-23 |
| HTY | 4 | 2025-06-24 |
| HWC | 3 | 2019-07-05 |
| OSH | 3 | 2013-05-08 |
| OWI | 2 | 2020-03-16 |
| JDW | 2 | 2017-02-13 |
| PGM | 1 | 2025-03-14 |
| MDI | 1 | 2024-01-20 |
| OLO | 1 | 2021-02-04 |
| MBI | 1 | 2013-06-20 |
PMN#
OrthoPediatrics PediFoot Deformity Corrections System
OrthoPediatrics, Corp
OrthoPediatrics Cannulated Screw System
Orthopediatrics, Corp
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
OrthoPediatrics, Corp
ORTHOPEDIATRICS BLADE PLATE SYSTEM
ORTHOPEDIATRICS, CORP
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
ORTHOPEDIATRICS, CORP