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Component, Cast

FDA product code LGF · 31 cleared devices

Class 1 Orthopedic

Regulation: 21 CFR 888.5940
Review panel: OR
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: Yes
Clearance span: 1978-03-17 – 2005-03-10

LGF 2005-03-10

SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC

Applicant Noble Fiber Technologies, Inc.

K number K043526

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LGF 1997-12-09

CLINITEX CAST PADDING

Applicant Clinitex Medical Corp.

K number K973420

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LGF 1997-12-09

CLINITEX STOCKINETTE

Applicant Clinitex Medical Corp.

K number K973417

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LGF 1996-01-26

PROTEC COTTON PADDING BANDAGE

Applicant Derivadas Degasa S.A. DE C.V.

K number K955320

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LGF 1994-02-23

QUICK-CAST IMMOBILIZER

Applicant Landec Corp.

K number K932507

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LGF 1993-12-15

CARAPACE STERILE CAST PADDING

Applicant Carapace, Inc.

K number K931672

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LGF 1991-03-05

ARTIFLEX(TM)

Applicant Beiersdorf, Inc.

K number K910274

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LGF 1990-12-31

COOL CAST(R)

Applicant Hawthorne Products, Inc.

K number K903946

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LGF 1990-06-14

CARAGLAS XTRA SYNTHETIC CASTING TAPE

Applicant Buckman Co., Inc.

K number K896634

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LGF 1988-08-30

SYNTHETIC CAST TAPE

Applicant Carapace, Inc.

K number K883294

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LGF 1987-12-30

COLORED CASTING TAPE CARAGLAS(TM GREEN

Applicant Synthetic Mfg., Inc.

K number K874880

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LGF 1987-10-02

PEDESTAL WALKING HEEL PRODUCT NO. 4183-133

Applicant Martin Medical

K number K873722

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LGF 1987-10-02

CHILD WALKING HEEL PRODUCT NO. 4183-132

Applicant Martin Medical

K number K873718

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LGF 1987-10-02

CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135

Applicant Martin Medical

K number K873717

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LGF 1987-02-13

COLORED CASTING TAPE (RED AND BLUE)

Applicant Buckman Co., Inc.

K number K870404

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LGF 1986-12-16

OEC DESIGN ORTHOPEDIC CAST HEEL

Applicant Military Engineering, Inc.

K number K864092

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LGF 1986-03-28

AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202

Applicant Martin Medical

K number K861075

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LGF 1986-03-28

AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200

Applicant Martin Medical

K number K861074

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LGF 1986-03-28

AMERICAN ORTHOPAEDIC VACUUM 0295-250

Applicant Martin Medical

K number K861073

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LGF 1985-12-11

DELTA-LITE CASTING RESIN

Applicant Johnson & Johnson Professionals, Inc.

K number K854554

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LGF 1985-11-22

DELTA-LITE CASTING RESIN

Applicant Johnson & Johnson Professionals, Inc.

K number K854341

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LGF 1984-11-14

VENT-A-CAST

Applicant Orthopedic Technology, Inc.

K number K843780

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LGF 1984-03-23

MASTERFOOT CAST HEEL

Applicant Seton Products, Inc.

K number K840617

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LGF 1983-10-14

MASTERHINGE

Applicant Mark One Healthcare Products

K number K833084

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LGF 1983-01-14

CAST TOE COVER

Applicant Danek Medical, Inc.

K number K823819

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LGF 1982-12-03

WALKING HEEL

Applicant Orthopedic Systems, Inc.

K number K823394

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LGF 1982-07-22

SHOW'RBAG

Applicant The Healthcare Group Laboratories, Inc.

K number K822059

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LGF 1982-01-18

STERILE ORTHOPEDIC STOCKINETTE

Applicant Alba Health Care

K number K812904

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LGF 1981-01-26

COBBLER'S CHIP SPLINTS

Applicant Secol Co.

K number K810110

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LGF 1981-01-09

CONPHAR CAST HEELS

Applicant Conphar, Inc.

K number K803141

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LGF 1978-03-17

INSERTER, PLUG, BONE, LIDGE

Applicant Depuy, Inc.

K number K780283

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