Freedom DS 35-0013-000
Freedom DS 35-0013-000 is a Class II device made by Spinal Simplicity, LLC, cleared under FDA 510(k) K253523 on 16 Apr 2026 and listed in FDA GUDID since 7 May 2026 (UDI-DI M9433500130000), 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 | NumberM9433500130000 | Date7 May 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK253523 | Date16 Apr 2026 | StatusActive |
Official records
- FDA 510(k) database K253523
Across registries
- FDA 510(k) K253523 decided 16 Apr 2026 Active
- FDA GUDID UDI-DI M9433500130000 listed 7 May 2026 Listed
Timeline
- Cleared FDA 510(k) K253523
- Listed FDA GUDID M9433500130000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Freedom DS
- Generic name
- Neurosurgical procedure kit, non-medicated, single-use
- Model / reference
- 35-0013-000
- Primary DI / UDI-DI
- M9433500130000
- 510(k) Number
- FDA product code
- HAE, HRX
- GMDN term
- Neurosurgical procedure kit, non-medicated, single-use
- Device class
- Class II
- Regulation number
- 882.4840, 888.1100
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HAE (Rongeur, Manual).
- NEUROLOGICAL RONGEURS - VARIOUS TYPES by Zinnanti Surgical Instruments, Inc.
- MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES by Baxano, Inc.
- Rebellion; Phantom Multi-Bite Kerrison Rongeur by Morpheus AG
- BAXANO ULTRA LOW PROFILE RONGEUR by Baxano, Inc.
- Symmetry Sharp Kerrison Rongeur by SYMMETRY SURGICAL INC.
- Rebellion, Phantom Multi-Bite Kerrison Rongeur by Morpheus AG
- LAMINECTOMY RONGEUR by Zeppelin GmbH
- RONGEUR (NEUROSURGICAL INSTRUMENTS) by Solway, Inc.
- Steribite by Rjr Surgical, Inc.
- KERRISON RONGEURS by Enterprise Medical Corp.