FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANSPACH KNOTLESS ANCHOR
K Number: K052572
·
Decision Dec 5, 2005
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
60
Review Days
77
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
- ANSPACH KNOTLESS ANCHOR
- K Number
- K052572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Anspach Effort, Inc.
- Date Received
- September 19, 2005
- Decision Date
- December 5, 2005
- 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 The Anspach Effort, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | May 19, 2022 | Substantially Equivalent |
| K183545 | Anspach Helix Dissection Tools | Jul 19, 2019 | Substantially Equivalent |
| K180063 | OCM-G1 Attachment | Mar 27, 2018 | Substantially Equivalent |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | Jan 10, 2014 | Substantially Equivalent |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | Dec 31, 2013 | Substantially Equivalent |
| K113476 | ANSPACH DISSECTION TOOLS | Dec 16, 2011 | Substantially Equivalent |
| K082637 | CRANIAL PERFORATOR | Dec 22, 2008 | Substantially Equivalent |
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | Apr 30, 2008 | Substantially Equivalent |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | Jan 26, 2007 | Substantially Equivalent |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | Jan 16, 2007 | Substantially Equivalent |