Stretto 6231.8010
Stretto 6231.8010 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K231333 on 4 Aug 2023 and listed in FDA GUDID since 28 Sep 2023 (UDI-DI 00193982511210), 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 | Number00193982511210 | Date28 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231333 | Date4 Aug 2023 | StatusActive |
Official records
- AccessGUDID record 00193982511210
- FDA 510(k) database K231333
Across registries
- FDA 510(k) K231333 decided 4 Aug 2023 Active
- FDA GUDID UDI-DI 00193982511210 listed 28 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K231333
- Listed FDA GUDID 00193982511210
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stretto
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Model / reference
- 6231.8010
- Primary DI / UDI-DI
- 00193982511210
- 510(k) Number
- FDA product code
- HWC, JDQ, HRS
- GMDN term
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device class
- Class II
- Regulation number
- 888.3040, 888.3010, 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic surgical procedure kit, non-medicated, reusable.
- Knee Instruments 02.19.10.0019 by Medacta International SA
- Knee Instruments 02.12.10.1157 by Medacta International SA
- ERISMA® LP_NAVIGATED INSTRUMENTS 48710004 by Clariance, Inc.
- Humelock Reversed Shoulder 902-0002 by FX SOLUTIONS
- Idys™- TLIF 31761000 by Clariance, Inc.
- Optimized Ortho Positioning (OPS) System 1248-0033 by OPTIMIZED ORTHO PTY LTD
- KneeAlign 2 401548 by Orthalign, Inc.
- 07-30962 by Stryker GmbH