FDA product code LGF: Component, Cast
LGF is the FDA product code for component, cast. It is a Class I device, regulated under 21 CFR 888.5940 and reviewed by the Orthopedic panel. FDA has cleared 31 510(k) submissions under LGF, from 22 different applicants. The average 510(k) review took 58 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Component, Cast |
| Device class | Class I |
| Regulation | 21 CFR 888.5940 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every LGF clearance
Top LGF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Martin Medical | 6 | 1987-10-02 |
| Clinitex Medical Corp. | 2 | 1997-12-09 |
| Carapace, Inc. | 2 | 1993-12-15 |
| Buckman Co., Inc. | 2 | 1990-06-14 |
| Johnson & Johnson Professionals, Inc. | 2 | 1985-12-11 |
17 more applicants have LGF clearances. See the full list in Caduvo.
Most recent LGF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K043526 | Noble Fiber Technologies, Inc. | SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC | 2005-03-10 | 79 |
| K973420 | Clinitex Medical Corp. | CLINITEX CAST PADDING | 1997-12-09 | 90 |
| K973417 | Clinitex Medical Corp. | CLINITEX STOCKINETTE | 1997-12-09 | 90 |
| K955320 | Derivadas Degasa S.A. DE C.V. | PROTEC COTTON PADDING BANDAGE | 1996-01-26 | 67 |
| K932507 | Landec Corp. | QUICK-CAST IMMOBILIZER | 1994-02-23 | 274 |
Recalls for LGF devices
openFDA lists no recalls for product code LGF.
Frequently asked questions
What is FDA product code LGF?
LGF is the FDA product code for component, cast. It is a Class I device, regulated under 21 CFR 888.5940 and reviewed by the Orthopedic panel.
What device class is LGF?
Class I, regulation 21 CFR 888.5940. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LGF?
Across 31 cleared submissions the average was 58 days from receipt to decision (median 28).
Which companies have the most LGF clearances?
Martin Medical (6); Clinitex Medical Corp. (2); Carapace, Inc. (2); Buckman Co., Inc. (2); Johnson & Johnson Professionals, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LGF
- Run a recall and safety report across every LGF manufacturer
- Watch product code LGF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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