SkyOPS 001-2-04-R
by Sky Surgical
SkyOPS 001-2-04-R is a Class I device made by Sky Surgical, cleared under FDA 510(k) K233154 on 21 Dec 2023 and listed in FDA GUDID since 23 Sep 2024 (UDI-DI 00850024702363), 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 | Number00850024702363 | Date23 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233154 | Date21 Dec 2023 | StatusActive |
Official records
- AccessGUDID record 00850024702363
- FDA 510(k) database K233154
Across registries
- FDA 510(k) K233154 decided 21 Dec 2023 Active
- FDA GUDID UDI-DI 00850024702363 listed 23 Sep 2024 Listed
Timeline
- Cleared FDA 510(k) K233154
- Listed FDA GUDID 00850024702363
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SkyOPS
- Generic name
- Orthopaedic inorganic implant inserter/extractor, reusable
- Model / reference
- 001-2-04-R
- Primary DI / UDI-DI
- 00850024702363
- 510(k) Number
- FDA product code
- HWR
- GMDN term
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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