Recall Z-0412-2013— SpineFrontier, Inc.
Class II · Terminated
Class II FDA medical device recall by SpineFrontier, Inc., initiated 2012-08-28, terminated 2015-06-11. It names one FDA 510(k) clearance: K093438. Product: Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.. Reason: Inspan Compressors may break at weld causing a loss of compression.
- Recalling firm
- SpineFrontier, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-28
- Terminated
- 2015-06-11
- Firm location
- Beverly, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
Reason for recall
Inspan Compressors may break at weld causing a loss of compression
Data sourced from openFDA. This site is unofficial and independent of the FDA.