Product code ILH
- Device name
- Splint, Hand, And Components
- 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 |
|---|---|---|---|
| K832144 | SPLINT WOOD | Vermont Wood Industries, Inc. | 1983-08-01 |
| K831548 | SPLINTS | Fred Sammons, Inc. | 1983-06-27 |
| K823647 | FINGER EXTENSION SPLINT | Fred Sammons, Inc. | 1983-01-21 |
| K823644 | FINGER FLEXION SPLINT | Fred Sammons, Inc. | 1983-01-21 |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823601 | WRIST SUPPORT | Fred Sammons, Inc. | 1982-12-22 |
| K823393 | STAX FINGER SPLINTS | Orthopedic Systems, Inc. | 1982-12-03 |
| K823165 | WRIST SPLING & FOREARM SPLINT | Warm & Form, Orthopedic Materials | 1982-11-16 |
| K822651 | TOTAL FINGER FLEXION SPLINT | Alimed, Inc. | 1982-09-17 |
| K821637 | WIRE-FOAM MP FLEXION SPRING | Fred Sammons, Inc. | 1982-06-11 |
| K821635 | SOFT ULNAR DEVIATION SPLINTS | Fred Sammons, Inc. | 1982-06-11 |
| K820826 | STAX FINGER SPLINT | Conco Medical Co. | 1982-04-08 |
| K820382 | FROG SPLINT | Conco Medical Co. | 1982-03-01 |
| K820381 | FINGER PROTECTOR | Conco Medical Co. | 1982-03-01 |
| K820380 | CURVED FINGER SPLINT | Conco Medical Co. | 1982-03-01 |
| K820383 | FINGER COT | Conco Medical Co. | 1982-02-24 |
| K812654 | VELCRO FINGER/TOE SPLINT | Maddak, Inc. | 1981-09-25 |
| K812655 | VELCRO SPLINT STRAP FASTENERS | Maddak, Inc. | 1981-09-25 |
| K812349 | HAND SPLINTS & COMPONENTS | Fred Sammons, Inc. | 1981-09-11 |
| K810442 | HAND SPLINTS AND COMPONENTS | Fred Sammons, Inc. | 1981-03-04 |
| K810109 | METAL SPLINTS | Secol Co. | 1981-01-26 |
| K801707 | BK-1499 KAY-KPLINT HAND CONE/BK-1500 | Fred Sammons, Inc. | 1980-08-20 |
| K801714 | TRANS DISTAL JOINT FINGER EXTEN. SPLINT | Fred Sammons, Inc. | 1980-08-07 |
| K800143 | DYNAMIC EXTENSOR SPLINT | Biomet, Inc. | 1980-02-19 |
| K790182 | 2 VELCRO SPLINT STRAP | Fred Sammons, Inc. | 1979-02-15 |
| K790180 | PLATFORM SPLINTS | Fred Sammons, Inc. | 1979-02-13 |
| K790181 | SOFT SPLINT STRAPS | Fred Sammons, Inc. | 1979-02-13 |
| K772416 | PRE-FORMED SPLINT BLANKS | Fred Sammons, Inc. | 1978-01-05 |
| K772411 | PLATFORM SPLINTS | Fred Sammons, Inc. | 1978-01-05 |
| K772410 | RESTING PAN SPLINTS | Fred Sammons, Inc. | 1978-01-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10680651299854 | Halyard | O&M HALYARD, INC. | 2023-07-31 |
| 20680651299004 | Halyard | O&M HALYARD, INC. | 2023-06-07 |
| 14026704798497 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| 14026704798480 | PILLING | TELEFLEX INCORPORATED | 2022-12-08 |
| G088DSHTAKHLR0 | Panacea | Blake Manufacturing, Inc. | 2022-09-15 |
| 20680651527107 | Halyard | O&M HALYARD, INC. | 2020-11-18 |
| 20680651366003 | Halyard | O&M HALYARD, INC. | 2020-11-18 |
| 20680651299806 | Halyard | O&M HALYARD, INC. | 2020-11-18 |
| 20680651299707 | Halyard | O&M HALYARD, INC. | 2020-11-18 |
| 20680651299677 | Halyard | O&M HALYARD, INC. | 2020-11-18 |
| 10680651299205 | Halyard | O&M HALYARD, INC. | 2020-11-18 |
| 20680651299653 | Halyard | O&M HALYARD, INC. | 2020-11-18 |
| 10888277667198 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-06 |
| 10888277667242 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-06 |
| 10888277667181 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-06 |
| 10888277667174 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-05 |
| 10888277667235 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-05 |
| 10888277667204 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-05 |
| 20680651299905 | Halyard | O&M HALYARD, INC. | 2020-09-09 |
| 00049022739222 | Well at Walgreens | WALGREEN CO. | 2020-05-29 |
| 00049022739376 | Well at Walgreens | WALGREEN CO. | 2020-05-29 |
| 00049022997899 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022754812 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022747562 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022739789 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022739727 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022739710 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022739703 | Walgreens | WALGREEN CO. | 2020-05-14 |
| 00049022997677 | Walgreens | WALGREEN CO. | 2020-05-09 |
| 10381780460664 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |