Modal Total Hip System M-1435-2804
Modal Total Hip System M-1435-2804 is a Class II device made by Modal Manufacturing LLC, cleared under FDA 510(k) K143314 on 27 Feb 2015 and listed in FDA GUDID since 1 Jul 2018 (UDI-DI B035M143528041), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB035M143528041 | Date1 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143314 | Date27 Feb 2015 | StatusActive |
Official records
- FDA 510(k) database K143314
Across registries
- FDA 510(k) K143314 decided 27 Feb 2015 Active
- FDA GUDID UDI-DI B035M143528041 listed 1 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K143314
- Listed FDA GUDID B035M143528041
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Modal Total Hip System
- Generic name
- Femoral head prosthesis trial
- Model / reference
- M-1435-2804
- Primary DI / UDI-DI
- B035M143528041
- 510(k) Number
- FDA product code
- LZO, LPH
- GMDN term
- Femoral head prosthesis trial
- Device class
- Class II
- Regulation number
- 888.3353, 888.3358
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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