Product code IQI
- Device name
- Orthosis, Limb Brace
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3475
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143458 | Neurosplint | Neurospectrum, LLC | 2015-08-13 |
| K052771 | SENSOR WALK | Otto Bock Healthcare LP | 2006-05-03 |
| K031576 | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 | Surgitech, Inc. | 2003-07-31 |
| K926391 | ACCUFLEX DYNAMIC ELBOW ORTHOSIS | Regulatory & Marketing Services, Inc. | 1993-07-22 |
| K910974 | MCCONNELL SHOULDER BRACE | Mcconnell Orthopedic | 1991-03-21 |
| K874502 | GAIT-AID ORTHOPEDIC INSOLE | Gait-Aid, Inc. | 1987-11-30 |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Fred Sammons, Inc. | 1983-06-24 |
| K831615 | DROP FOOT BRACE | Edward Dilauro, Jr. | 1983-06-15 |
| K823812 | VARIOUS SUPPORTS AND SPLINTS | Danek Medical, Inc. | 1983-01-14 |
| K823113 | BRACE-UP ALL PURPOSE WRIST BAND | Arco Matic, Inc. | 1982-11-16 |
| K823160 | ROTATION BOOT | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K823114 | BRACE-UP STOCKING KNEE BRACE | Arco Matic, Inc. | 1982-11-05 |
| K822767 | UNIVERSAL DYNASPLINT | Dynasplint Systems, Inc. | 1982-10-06 |
| K822022 | SPORT SUPPORTS | Ginny, Inc. | 1982-07-26 |
| K821704 | FRACTURE BRACING | Hosmer Dorrance Corp. | 1982-06-24 |
| K821640 | ORTHOTIC FABRICATION ACCESSORIES | Fred Sammons, Inc. | 1982-06-11 |
| K821641 | OBTHOSES | Fred Sammons, Inc. | 1982-06-11 |
| K821582 | WARM'N FORM SPORTS SUPPORTS | Jerome Medical | 1982-06-10 |
| K820469 | WARM & FORM KNEE SUPPORTS | Thermo-Mold Medical Products, Inc. | 1982-03-08 |
| K811704 | MULTITUBULAR AIR SPLINT KIT | Roger Cestac & Assoc. | 1981-07-01 |
| K811690 | ANKLE-FOOT CAST/SPLINT | Surgical Appliance Industries, Inc. | 1981-06-25 |
| K811456 | ORTHO-FRAC KIT | Orthomedics | 1981-06-12 |
| K811490 | FOREARM & KNEE STRAPS | Fred Sammons, Inc. | 1981-06-12 |
| K811343 | HUMERAL FRACTURE CAST BRACE | Deseret Medical, Inc. | 1981-05-28 |
| K811035 | PRO COMFORT TENNIS ELBOW SUPPORT/WRIST | Scholl, Inc. | 1981-04-29 |
| K810443 | LIMB ORTHOSIS | Fred Sammons, Inc. | 1981-03-04 |
| K810288 | AIRCAST TENNIS ARM BAND | Aircast, Inc. | 1981-02-12 |
| K802910 | PLASTIC FRACTURE CAST BRACE KNEE JOINT | Orthomedics | 1980-12-22 |
| K802908 | ULNAR FRACTURE BRACE | Orthomedics | 1980-12-17 |
| K802909 | HUMERAL FRACTURE BRACE | Orthomedics | 1980-12-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840536823694 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824769 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824271 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824264 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824257 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824240 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824233 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824226 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824219 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824202 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824196 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824189 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824172 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536824165 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823700 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536801074 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823687 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823670 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823663 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823656 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823649 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823632 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823625 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823618 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823601 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823595 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823588 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536823571 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536806390 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |
| 00840536801081 | PediHip | ORTHOPEDIATRICS CORP. | 2026-10-01 |