Resorbable Mesh Device
by SeaSpine Orthopedics Corporation 2 variants
510(k) K193040
Resorbable Mesh Device is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K193040 on 30 Nov 2019, 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 | NumberK193040 | Date30 Nov 2019 | StatusActive |
Official records
- FDA 510(k) database K193040
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQV
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K193040
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 | |||
|---|---|---|---|---|
| Ballast™ 02-8000-160 | 02-8000-160 / 02-8000-160 | 10889981189259 | — | On the market |
| OsteoBallast™ 56800160 | 56800160 / 56800160 | 10889981189266 | — | On the market |
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