Paradigm 1100001
by Proprio
Paradigm 1100001 (1100003) is a Class II device made by Proprio, cleared under FDA 510(k) K222291 on 21 Apr 2023 and listed in FDA GUDID since 5 May 2023 (UDI-DI 00850042604007), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number00850042604007 | Date5 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222291 | Date21 Apr 2023 | StatusActive |
Official records
- AccessGUDID record 00850042604007
- FDA 510(k) database K222291
Across registries
- FDA 510(k) K222291 decided 21 Apr 2023 Active
- FDA GUDID UDI-DI 00850042604007 listed 5 May 2023 Listed
Timeline
- Cleared FDA 510(k) K222291
- Listed FDA GUDID 00850042604007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Paradigm
- Generic name
- Optical surgical navigation/tracking system
- Model / Ref / Catalog
- 1100001, 1100003
- Primary DI / UDI-DI
- 00850042604007
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Optical surgical navigation/tracking system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- Not in Commercial Distribution
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