FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Boomerang Anterior Cervical Plate System
K Number: K190227
·
Decision May 1, 2019
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
22
Review Days
85
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Basic Information
- Device Name
- Boomerang Anterior Cervical Plate System
- K Number
- K190227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Choicespine, LP
- Date Received
- February 5, 2019
- Decision Date
- May 1, 2019
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Choicespine, LP
| K Number | Device Name | ||
|---|---|---|---|
| K183397 | ChoiceSpine Stealth Cervical Spacer System | Mar 6, 2019 | Substantially Equivalent |
| K182721 | Choice Spine Navigation System | Jan 8, 2019 | Substantially Equivalent |
| K183214 | Raven Lumbar Plate System | Jan 3, 2019 | Substantially Equivalent |
| K180519 | HARRIER-SA Lumbar Interbody System | May 16, 2018 | Substantially Equivalent |
| K172816 | TiGer Shark System | Jan 26, 2018 | Substantially Equivalent |
| K173215 | Choice Spine Laminoplasty Fixation System | Jan 19, 2018 | Substantially Equivalent |
| K171489 | Acapella Cervical Spacer System | Oct 23, 2017 | Substantially Equivalent |
| K170821 | ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System | Jun 8, 2017 | Substantially Equivalent |
| K170942 | The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems | Apr 26, 2017 | Substantially Equivalent |
| K170953 | Tomcat Cervical Spinal System | Apr 21, 2017 | Substantially Equivalent |