Rps 8800050000
Rps 8800050000 (8800-050-000) is a surgical power tool system control unit (FDA Class II; FDA product code OLO, Orthopedic stereotaxic instrument) made by Stryker Corp., listed in FDA GUDID since 10 Oct 2025 (UDI-DI 07613327627558), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07613327627558 | Date10 Oct 2025 | StatusListed |
Official records
- AccessGUDID record 07613327627558
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Rps
- Generic name
- Surgical power tool system control unit, line-powered
- Model / Ref / Catalog
- 8800050000, 8800-050-000
- Primary DI / UDI-DI
- 07613327627558
- FDA product code
- OLO
- GMDN term
- Surgical power tool system control unit, line-powered
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code OLO (Orthopedic stereotaxic instrument).
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- CD HORIZON® Spinal System RBT011211 by MEDTRONIC SOFAMOR DANEK, INC.
- 6003-080-001 by Stryker Leibinger
- 111110 by MAKO Surgical Corp.
- Mako Total Knee Application by MAKO Surgical Corp.
- Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter by Smith & Nephew, Inc.