FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXYALOOP NONABSORBABLE BONE ANCHOR
K Number: K060970
·
Decision Jul 5, 2006
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
19
Review Days
89
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
- AXYALOOP NONABSORBABLE BONE ANCHOR
- K Number
- K060970
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axya Medical, Inc.
- Date Received
- April 7, 2006
- Decision Date
- July 5, 2006
- Product Code
- JDR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDR), ordered by most recent decision date.
Linkt Compression Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex DynaNite Nitinol Staples
FDA 510(k)
FDA Class 2
·Orthopedic
TMC Compression Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
TMC Compression Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
COGNiTiON Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Axya Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070773 | AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR | Oct 11, 2007 | Substantially Equivalent |
| K070253 | AXYA SUTURE WELDING SYSTEM AND KIT | Jul 11, 2007 | Substantially Equivalent |
| K063194 | TUFFLEX POLYESTER SUTURE | Dec 4, 2006 | Substantially Equivalent |
| K060165 | AXYAFLEX POLYESTER SUTURE | Sep 1, 2006 | Substantially Equivalent |
| K052491 | AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR | Oct 7, 2005 | Substantially Equivalent |
| K051983 | MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR | Aug 5, 2005 | Substantially Equivalent |
| K051250 | AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR | Jun 9, 2005 | Substantially Equivalent |
| K041698 | AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR | Oct 5, 2004 | Substantially Equivalent |
| K022207 | AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM | Oct 4, 2002 | Substantially Equivalent |
| K021929 | AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM | Sep 10, 2002 | Substantially Equivalent |