FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
K Number: K052491
·
Decision Oct 7, 2005
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
19
Review Days
25
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Basic Information
- Device Name
- AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
- K Number
- K052491
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axya Medical, Inc.
- Date Received
- September 12, 2005
- Decision Date
- October 7, 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 |
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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 |
| K060970 | AXYALOOP NONABSORBABLE BONE ANCHOR | Jul 5, 2006 | 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 |