Product code LGF
- Device name
- Component, Cast
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.5940
- Review panel
- OR
- 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 |
|---|---|---|---|
| K043526 | SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC | Noble Fiber Technologies, Inc. | 2005-03-10 |
| K973420 | CLINITEX CAST PADDING | Clinitex Medical Corp. | 1997-12-09 |
| K973417 | CLINITEX STOCKINETTE | Clinitex Medical Corp. | 1997-12-09 |
| K955320 | PROTEC COTTON PADDING BANDAGE | Derivadas Degasa S.A. DE C.V. | 1996-01-26 |
| K932507 | QUICK-CAST IMMOBILIZER | Landec Corp. | 1994-02-23 |
| K931672 | CARAPACE STERILE CAST PADDING | Carapace, Inc. | 1993-12-15 |
| K910274 | ARTIFLEX(TM) | Beiersdorf, Inc. | 1991-03-05 |
| K903946 | COOL CAST(R) | Hawthorne Products, Inc. | 1990-12-31 |
| K896634 | CARAGLAS XTRA SYNTHETIC CASTING TAPE | Buckman Co., Inc. | 1990-06-14 |
| K883294 | SYNTHETIC CAST TAPE | Carapace, Inc. | 1988-08-30 |
| K874880 | COLORED CASTING TAPE CARAGLAS(TM GREEN | Synthetic Mfg., Inc. | 1987-12-30 |
| K873722 | PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 | Martin Medical | 1987-10-02 |
| K873718 | CHILD WALKING HEEL PRODUCT NO. 4183-132 | Martin Medical | 1987-10-02 |
| K873717 | CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 | Martin Medical | 1987-10-02 |
| K870404 | COLORED CASTING TAPE (RED AND BLUE) | Buckman Co., Inc. | 1987-02-13 |
| K864092 | OEC DESIGN ORTHOPEDIC CAST HEEL | Military Engineering, Inc. | 1986-12-16 |
| K861075 | AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202 | Martin Medical | 1986-03-28 |
| K861074 | AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200 | Martin Medical | 1986-03-28 |
| K861073 | AMERICAN ORTHOPAEDIC VACUUM 0295-250 | Martin Medical | 1986-03-28 |
| K854554 | DELTA-LITE CASTING RESIN | Johnson & Johnson Professionals, Inc. | 1985-12-11 |
| K854341 | DELTA-LITE CASTING RESIN | Johnson & Johnson Professionals, Inc. | 1985-11-22 |
| K843780 | VENT-A-CAST | Orthopedic Technology, Inc. | 1984-11-14 |
| K840617 | MASTERFOOT CAST HEEL | Seton Products, Inc. | 1984-03-23 |
| K833084 | MASTERHINGE | Mark One Healthcare Products | 1983-10-14 |
| K823819 | CAST TOE COVER | Danek Medical, Inc. | 1983-01-14 |
| K823394 | WALKING HEEL | Orthopedic Systems, Inc. | 1982-12-03 |
| K822059 | SHOW'RBAG | The Healthcare Group Laboratories, Inc. | 1982-07-22 |
| K812904 | STERILE ORTHOPEDIC STOCKINETTE | Alba Health Care | 1982-01-18 |
| K810110 | COBBLER'S CHIP SPLINTS | Secol Co. | 1981-01-26 |
| K803141 | CONPHAR CAST HEELS | Conphar, Inc. | 1981-01-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G064208317270091511 | CastWedge™ | POSITION HEALTH, LLC | 2022-12-09 |
| G064208317270092051 | CastWedge™ | POSITION HEALTH, LLC | 2022-12-09 |
| G064208317270092501 | CastWedge™ | POSITION HEALTH, LLC | 2022-12-09 |
| G064208317270093041 | CastWedge™ | POSITION HEALTH, LLC | 2022-12-09 |
| G064208317270091061 | CastWedge™ | POSITION HEALTH, LLC | 2022-12-09 |
| 00632195002493 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-12-15 |
| 00632195002516 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-12-15 |
| 00632195002509 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-12-15 |
| 00632195002486 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-12-15 |
| 00632195002479 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-12-15 |
| 00632195002462 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-12-15 |
| 00632195001694 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-12-15 |
| 00632195000659 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-12-15 |
| 00632195000505 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-10-29 |
| 00632195000529 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-10-29 |
| 00632195000543 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-10-29 |
| 00632195000567 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-10-29 |
| 00632195000581 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-10-29 |
| 00632195000604 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-10-29 |
| 00632195000628 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-10-29 |
| 00632195000642 | Tex-Care Medical | Flynt/Amtex, Inc. | 2021-10-29 |
| 00817740020072 | BIONIX RADIATION THERAPY | Bionix Radiation Therapy, LLC | 2017-04-25 |
| 10817740020079 | BIONIX RADIATION THERAPY | BIONIX RADIATION THERAPY, LLC | 2017-04-25 |