ITMClass I
Cage, Knee
21 CFR 890.3475 / Physical Medicine
ITM is the FDA product code for Cage, Knee, a class I device type, regulated under 21 CFR 890.3475. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- ITM
- Device name
- Cage, Knee
- Regulation
- 21 CFR 890.3475
- Device class
- Class I
- Review panel
- Physical Medicine
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code ITM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1981 | 1 |
| 1983 | 1 |
Applicants with the most clearances
Product code ITM| Applicant | Clearances |
|---|---|
| Chase Mfg. Co. | 2 |
| Generation II Orthotics, Inc. | 1 |
| Orthomedics | 1 |
| Richard'S Medical Equip., Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Allmay Bodywear (Shenzhen) Co., Ltd
- Allmay International Limited
- Antar Sp. J.
- Beijing Jinwei Kangda Medical Instrument Ltd.
- Bort GmbH
- Cascade Orthopedic Supply, LP.
- CBR Enterprise Limited
- Comfortland International, LLC
- DJO, LLC
- DJO, LLC
- Dong Guan Yunzhishang Health Technology Co.,Ltd.
- Dongguan Redthera Technology Co., Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
