SPINE FRONTIER INDUS ACP SYSTEM
FDA 510(k) clearance K121060 · decided 2012-07-03
Clearance details
- K-number
- K121060
- Device name
- SPINE FRONTIER INDUS ACP SYSTEM
- Applicant
- Spinefrontier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-06
- Decision date
- 2012-07-03
- Days to decision
- 88 days
- Clearance type
- Special
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Ant recall (Z-0573-2014) | SpineFrontier, Inc. | 2013-12-26 |
| Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue recall (Z-0574-2014) | SpineFrontier, Inc. | 2013-12-26 |
| Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cer recall (Z-0575-2014) | SpineFrontier, Inc. | 2013-12-26 |
| Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue A recall (Z-0576-2014) | SpineFrontier, Inc. | 2013-12-26 |
| Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw recall (Z-1957-2013) | SpineFrontier, Inc. | 2013-08-13 |
| Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within th recall (Z-1933-2013) | SpineFrontier, Inc. | 2013-08-08 |