Instrument, Cast Application/Removal, Manual
A manual cast application and removal instrument is a hand-operated tool used by orthopedic clinicians to apply, shape, and remove plaster or synthetic casts during the treatment of fractures and other musculoskeletal conditions. The device is FDA Class 1, the lowest risk category, subject only to general controls and not requiring premarket notification. It carries product code LGG and is regulated under 21 CFR 888.5980 within the Orthopedic specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- LGG
- Device Class
- FDA class 1
- Regulation Number
- 888.5980
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K870100 | PLASTER STAND | Jan 28, 1987 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K851786 | 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF | Jul 09, 1985 | Substantially Equivalent | Artiberia |
| K834384 | MODULAR EXTREMITY CASTING SUPPORT | Jan 30, 1984 | Substantially Equivalent | Buckman Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 103 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 103 registration numbers. Click on an entry to view related FDA registrations.