Resorbable Mesh Device
FDA 510(k) clearance K172130 · decided 2017-11-16
Clearance details
- K-number
- K172130
- Device name
- Resorbable Mesh Device
- Applicant
- SeaSpine Orthopedics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-07-14
- Decision date
- 2017-11-16
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis recall (Z-2820-2026) | IsoTis OrthoBiologics, Inc. | 2026-07-28 |