CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
FDA 510(k) clearance K133455 · decided 2014-03-27
Clearance details
- K-number
- K133455
- Device name
- CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
- Applicant
- Pioneer Surgical Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-12
- Decision date
- 2014-03-27
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Marquette, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(1 recall (Z-1916-2015) | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 2015-06-26 |