Indy 1030-0811
by Altus Spine
Indy 1030-0811 is a Class I device made by Altus Spine, cleared under FDA 510(k) K182406 on 22 Feb 2019 and listed in FDA GUDID since 24 Jul 2024 (UDI-DI 00843210171005), 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 | Number00843210171005 | Date24 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182406 | Date22 Feb 2019 | StatusActive |
Official records
- AccessGUDID record 00843210171005
- FDA 510(k) database K182406
Across registries
- FDA 510(k) K182406 decided 22 Feb 2019 Active
- FDA GUDID UDI-DI 00843210171005 listed 24 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K182406
- Listed FDA GUDID 00843210171005
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Indy
- Generic name
- Orthopaedic surgical distractor, internal
- Model / reference
- 1030-0811
- Primary DI / UDI-DI
- 00843210171005
- 510(k) Number
- FDA product code
- LXH
- GMDN term
- Orthopaedic surgical distractor, internal
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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