FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER WEDGE SUTURE ANCHOR
K Number: K983557
·
Decision Dec 18, 1998
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
101
Review Days
66
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STRYKER WEDGE SUTURE ANCHOR
- K Number
- K983557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Endoscopy
- Date Received
- October 13, 1998
- Decision Date
- December 18, 1998
- 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.
Dione PEEK Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Y-Knotless Flex Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
Anchor with Fiber Wire and Disposable Inserter
FDA 510(k)
FDA Class 2
·Orthopedic
ArthroTAK Tendon Anchor Kit
FDA 510(k)
FDA Class 2
·Orthopedic
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex FiberTak Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Stryker Endoscopy
| K Number | Device Name | ||
|---|---|---|---|
| K253602 | Precision S 4K Sinuscope | Jun 4, 2026 | Substantially Equivalent |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | May 28, 2026 | Substantially Equivalent |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Feb 18, 2026 | Substantially Equivalent |
| K260108 | L12 LED Light Source with AIM | Feb 12, 2026 | Substantially Equivalent |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Jan 13, 2026 | Substantially Equivalent |
| K253888 | MOLLI 2 System | Dec 31, 2025 | Substantially Equivalent |
| K252010 | SPY Laparoscope | Jul 24, 2025 | Substantially Equivalent |
| K252012 | SPY Cystoscope/Hysteroscope | Jul 18, 2025 | Substantially Equivalent |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | May 23, 2025 | Substantially Equivalent |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite Anchor | May 21, 2025 | Substantially Equivalent |