Ingenix 50090825
Ingenix 50090825 is a Class II device made by Ingenium Spine, cleared under FDA 510(k) K173126 on 5 Dec 2017 and listed in FDA GUDID since 15 Jun 2018 (UDI-DI 00843672101466), active as of 22 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 | Number00843672101466 | Date15 Jun 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173126 | Date5 Dec 2017 | StatusActive |
Official records
- AccessGUDID record 00843672101466
- FDA 510(k) database K173126
Across registries
- FDA 510(k) K173126 decided 5 Dec 2017 Active
- FDA GUDID UDI-DI 00843672101466 listed 15 Jun 2018 Listed
Timeline
- Cleared FDA 510(k) K173126
- Listed FDA GUDID 00843672101466
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ingenix
- Generic name
- Bone-screw internal spinal fixation system, non-sterile
- Model / reference
- 50090825
- Primary DI / UDI-DI
- 00843672101466
- 510(k) Number
- FDA product code
- KWP, NKB
- GMDN term
- Bone-screw internal spinal fixation system, non-sterile
- Device class
- Class II
- Regulation number
- 888.3050, 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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- AUGMENT POSTERIOR SPINAL FIXATION SYSTEM by Sofamor Danek Mfg., Inc.
- CENTRA-LINE GRAPPLE, VARIFIX SYSTEM by Advanced Spine Fixation Systems, Inc.
- A HOOK DRIVER by Twin City Surgical, Inc.