Sponger Cable System, Modification
by Pioneer Surgical Technology
510(k) K935481
Sponger Cable System, Modification is a Class II device made by Pioneer Surgical Technology, cleared under FDA 510(k) K935481 on 26 Jan 1994, 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 | FDA 510(k)SESE | NumberK935481 | Date26 Jan 1994 | StatusActive |
Official records
- FDA 510(k) database K935481
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JDQ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3010
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K935481
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SONGER® SPINAL CABLE SYSTEM 186.200S | 186.200S / 186.200S | 00846468023591 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 186.201S | 186.201S / 186.201S | 00846468023607 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 186.202S | 186.202S / 186.202S | 00846468023614 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 286.100S | 286.100S / 286.100S | 00846468030308 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 286.101S | 286.101S / 286.101S | 00846468030315 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 286.102S | 286.102S / 286.102S | 00846468030322 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 686.301 | 686.301 | 00846468061876 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 686.302 | 686.302 | 00846468061883 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 686.303 | 686.303 | 00846468061890 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 686.303 | 686.303 | 00846468061906 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 686.304 | 686.304 | 00846468061913 | — | No longer on the market |
| SONGER® SPINAL CABLE SYSTEM 986.1 | 986.1 | 00846468047962 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code JDQ (Cerclage, Fixation).
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