Product Code: LGF FDA class 1 21 CFR 888.5940

Component, Cast

Orthopedic

A cast component is an orthopedic device accessory used in the application and maintenance of plaster or synthetic casts for immobilizing fractures, dislocations, and other musculoskeletal injuries. The device is FDA Class 1, the lowest risk category, subject only to general controls without requiring premarket notification. It carries product code LGF and is regulated under 21 CFR 888.5940 within the Orthopedic specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: LGF
Device Class: FDA class 1
Regulation Number: 888.5940
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K043526	SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC	Mar 10, 2005	Substantially Equivalent	Noble Fiber Technologies, Inc.
K973420	CLINITEX CAST PADDING	Dec 09, 1997	Substantially Equivalent	Clinitex Medical Corp.
K973417	CLINITEX STOCKINETTE	Dec 09, 1997	Substantially Equivalent	Clinitex Medical Corp.
K955320	PROTEC COTTON PADDING BANDAGE	Jan 26, 1996	Substantially Equivalent	Derivadas Degasa S.A. DE C.V.
K932507	QUICK-CAST IMMOBILIZER	Feb 23, 1994	Substantially Equivalent	Landec Corp.
K931672	CARAPACE STERILE CAST PADDING	Dec 15, 1993	Substantially Equivalent	Carapace, Inc.
K910274	ARTIFLEX(TM)	Mar 05, 1991	Substantially Equivalent	Beiersdorf, Inc.
K903946	COOL CAST(R)	Dec 31, 1990	Substantially Equivalent	Hawthorne Products, Inc.
K896634	CARAGLAS XTRA SYNTHETIC CASTING TAPE	Jun 14, 1990	Substantially Equivalent	Buckman Co., Inc.
K883294	SYNTHETIC CAST TAPE	Aug 30, 1988	Substantially Equivalent	Carapace, Inc.
K874880	COLORED CASTING TAPE CARAGLAS(TM GREEN	Dec 30, 1987	Substantially Equivalent	Synthetic Mfg., Inc.
K873722	PEDESTAL WALKING HEEL PRODUCT NO. 4183-133	Oct 02, 1987	Substantially Equivalent	Martin Medical
K873718	CHILD WALKING HEEL PRODUCT NO. 4183-132	Oct 02, 1987	Substantially Equivalent	Martin Medical
K873717	CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135	Oct 02, 1987	Substantially Equivalent	Martin Medical
K870404	COLORED CASTING TAPE (RED AND BLUE)	Feb 13, 1987	Substantially Equivalent	Buckman Co., Inc.
K864092	OEC DESIGN ORTHOPEDIC CAST HEEL	Dec 16, 1986	Substantially Equivalent	Military Engineering, Inc.
K861075	AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202	Mar 28, 1986	Substantially Equivalent	Martin Medical
K861074	AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200	Mar 28, 1986	Substantially Equivalent	Martin Medical
K861073	AMERICAN ORTHOPAEDIC VACUUM 0295-250	Mar 28, 1986	Substantially Equivalent	Martin Medical
K854554	DELTA-LITE CASTING RESIN	Dec 11, 1985	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K854341	DELTA-LITE CASTING RESIN	Nov 22, 1985	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K843780	VENT-A-CAST	Nov 14, 1984	Substantially Equivalent	Orthopedic Technology, Inc.
K840617	MASTERFOOT CAST HEEL	Mar 23, 1984	Substantially Equivalent	Seton Products, Inc.
K833084	MASTERHINGE	Oct 14, 1983	Substantially Equivalent	Mark One Healthcare Products
K823819	CAST TOE COVER	Jan 14, 1983	Substantially Equivalent	Danek Medical, Inc.
K823394	WALKING HEEL	Dec 03, 1982	Substantially Equivalent	Orthopedic Systems, Inc.
K822059	SHOW'RBAG	Jul 22, 1982	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K812904	STERILE ORTHOPEDIC STOCKINETTE	Jan 18, 1982	Substantially Equivalent	Alba Health Care
K810110	COBBLER'S CHIP SPLINTS	Jan 26, 1981	Substantially Equivalent	Secol Co.
K803141	CONPHAR CAST HEELS	Jan 09, 1981	Substantially Equivalent	Conphar, Inc.
K780283	INSERTER, PLUG, BONE, LIDGE	Mar 17, 1978	Substantially Equivalent	Depuy, Inc.