FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIP MIS Interspinous Fusion System
K Number: K221399
·
Decision Jul 8, 2022
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
47
Applicant Total
7
Review Days
56
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Basic Information
- Device Name
- ZIP MIS Interspinous Fusion System
- K Number
- K221399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aurora Spine, Inc.
- Date Received
- May 13, 2022
- Decision Date
- July 8, 2022
- Product Code
- PEK
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PEK | Spinous Process Plate | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PEK), ordered by most recent decision date.
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Other Clearances by Aurora Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221047 | SILO TFX MIS Sacroiliac Joint Fixation System | Oct 3, 2022 | Substantially Equivalent |
| K220610 | SOLO-L | May 27, 2022 | Substantially Equivalent |
| K210521 | DEXA-C Cervical Interbody System | Aug 2, 2021 | Substantially Equivalent |
| K210325 | APOLLO Anterior Cervical Plate (ACP) System | Mar 23, 2021 | Substantially Equivalent |
| K141317 | ZIP MIS INTERSPINOUS FUSION SYSTEM | Nov 17, 2014 | Substantially Equivalent |
| K140715 | ZIP MIS INTERSPINOUS FUSION SYSTEM | Apr 17, 2014 | Substantially Equivalent |