FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Flower Suture Anchor Set
K Number: K192949
·
Decision Oct 7, 2020
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
8
Review Days
355
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Basic Information
- Device Name
- Flower Suture Anchor Set
- K Number
- K192949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Flower Orthopedics Corporation
- Date Received
- October 18, 2019
- Decision Date
- October 7, 2020
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Flower Orthopedics Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K170687 | Flower Bone Screw Set | Jun 6, 2017 | Substantially Equivalent |
| K142306 | Flower Upper Extremity Plating Set | Sep 15, 2014 | Substantially Equivalent |
| K133930 | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET | Mar 27, 2014 | Substantially Equivalent |
| K133102 | FLOWER ANKLE PLATING SET | Nov 18, 2013 | Substantially Equivalent |
| K132248 | FLOWER BONE SCREW SET | Oct 30, 2013 | Substantially Equivalent |
| K131657 | FLOWER SMALL AND MEDIUM IMPLANT SET | Aug 22, 2013 | Substantially Equivalent |
| K123562 | FLOWER SMALL AND MEDIUM BONE IMPLANTS | Mar 29, 2013 | Substantially Equivalent |