FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Flexible Suturing System with Anchors (FSSA)
K Number: K222589
·
Decision Jan 26, 2023
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
564
Applicant Total
1
Review Days
153
Basic Information
- Device Name
- Flexible Suturing System with Anchors (FSSA)
- K Number
- K222589
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integrity Orthopaedics, Inc.
- Date Received
- August 26, 2022
- Decision Date
- January 26, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBI), ordered by most recent decision date.
Arthrex PushLock Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
SnugFit ASA Extension
FDA 510(k)
FDA Class 2
·Orthopedic
BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)
FDA 510(k)
FDA Class 2
·Orthopedic
CONMED Argo Knotless® Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop
FDA 510(k)
FDA Class 2
·Orthopedic
Shoulder Soft Tissue Anchors
FDA 510(k)
FDA Class 2
·Orthopedic