LGF · Component, Cast
Orthopedic · 21 CFR 888.5940 · Class 1
Overview
| Product Code | LGF |
|---|---|
| Device Name | Component, Cast |
| Regulation | 21 CFR 888.5940 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
| GMP Exempt | Yes |
Identification
A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (31)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K043526 | SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC | Noble Fiber Technologies, Inc. | Mar 10, 2005 | SESE |
| K973420 | CLINITEX CAST PADDING | Clinitex Medical Corp. | Dec 9, 1997 | SESE |
| K973417 | CLINITEX STOCKINETTE | Clinitex Medical Corp. | Dec 9, 1997 | SESE |
| K955320 | PROTEC COTTON PADDING BANDAGE | Derivadas Degasa S.A. DE C.V. | Jan 26, 1996 | SESE |
| K932507 | QUICK-CAST IMMOBILIZER | Landec Corp. | Feb 23, 1994 | SESE |
| K931672 | CARAPACE STERILE CAST PADDING | Carapace, Inc. | Dec 15, 1993 | SESE |
| K910274 | ARTIFLEX(TM) | Beiersdorf, Inc. | Mar 5, 1991 | SESE |
| K903946 | COOL CAST(R) | Hawthorne Products, Inc. | Dec 31, 1990 | SESE |
| K896634 | CARAGLAS XTRA SYNTHETIC CASTING TAPE | Buckman Co., Inc. | Jun 14, 1990 | SESE |
| K883294 | SYNTHETIC CAST TAPE | Carapace, Inc. | Aug 30, 1988 | SESE |
| K874880 | COLORED CASTING TAPE CARAGLAS(TM GREEN | Synthetic Mfg., Inc. | Dec 30, 1987 | SESE |
| K873722 | PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 | Martin Medical | Oct 2, 1987 | SESE |
| K873718 | CHILD WALKING HEEL PRODUCT NO. 4183-132 | Martin Medical | Oct 2, 1987 | SESE |
| K873717 | CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 | Martin Medical | Oct 2, 1987 | SESE |
| K870404 | COLORED CASTING TAPE (RED AND BLUE) | Buckman Co., Inc. | Feb 13, 1987 | SESE |
| K864092 | OEC DESIGN ORTHOPEDIC CAST HEEL | Military Engineering, Inc. | Dec 16, 1986 | SESE |
| K861075 | AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202 | Martin Medical | Mar 28, 1986 | SESE |
| K861074 | AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200 | Martin Medical | Mar 28, 1986 | SESE |
| K861073 | AMERICAN ORTHOPAEDIC VACUUM 0295-250 | Martin Medical | Mar 28, 1986 | SESE |
| K854554 | DELTA-LITE CASTING RESIN | Johnson & Johnson Professionals, Inc. | Dec 11, 1985 | SESE |
| K854341 | DELTA-LITE CASTING RESIN | Johnson & Johnson Professionals, Inc. | Nov 22, 1985 | SESE |
| K843780 | VENT-A-CAST | Orthopedic Technology, Inc. | Nov 14, 1984 | SESE |
| K840617 | MASTERFOOT CAST HEEL | Seton Products, Inc. | Mar 23, 1984 | SESE |
| K833084 | MASTERHINGE | Mark One Healthcare Products | Oct 14, 1983 | SESE |
| K823819 | CAST TOE COVER | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K823394 | WALKING HEEL | Orthopedic Systems, Inc. | Dec 3, 1982 | SESE |
| K822059 | SHOW'RBAG | The Healthcare Group Laboratories, Inc. | Jul 22, 1982 | SESE |
| K812904 | STERILE ORTHOPEDIC STOCKINETTE | Alba Health Care | Jan 18, 1982 | SESE |
| K810110 | COBBLER'S CHIP SPLINTS | Secol Co. | Jan 26, 1981 | SESE |
| K803141 | CONPHAR CAST HEELS | Conphar, Inc. | Jan 9, 1981 | SESE |
| K780283 | INSERTER, PLUG, BONE, LIDGE | Depuy, Inc. | Mar 17, 1978 | SESE |
Top Applicants
- Martin Medical — 6 clearances
- Johnson & Johnson Professionals, Inc. — 2 clearances
- Clinitex Medical Corp. — 2 clearances
- Carapace, Inc. — 2 clearances
- Buckman Co., Inc. — 2 clearances
