In2Bones P07 N0171
In2Bones P07 N0171 is a Class I device made by In2Bones, USA, cleared under FDA 510(k) K181113 on 15 Jun 2018 and listed in FDA GUDID since 12 Dec 2024 (UDI-DI 00810021865959), 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 | Number00810021865959 | Date12 Dec 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181113 | Date15 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 00810021865959
- FDA 510(k) database K181113
Across registries
- FDA 510(k) K181113 decided 15 Jun 2018 Active
- FDA GUDID UDI-DI 00810021865959 listed 12 Dec 2024 Listed
Timeline
- Cleared FDA 510(k) K181113
- Listed FDA GUDID 00810021865959
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- In2Bones
- Generic name
- Orthopaedic surgical distractor, external
- Model / Ref / Catalog
- P07 N0171
- Primary DI / UDI-DI
- 00810021865959
- 510(k) Number
- FDA product code
- LXH
- GMDN term
- Orthopaedic surgical distractor, external
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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