FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
K Number: K002435
·
Decision Aug 24, 2000
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
19
Review Days
15
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Basic Information
- Device Name
- MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
- K Number
- K002435
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axya Medical, Inc.
- Date Received
- August 9, 2000
- Decision Date
- August 24, 2000
- Product Code
- GAW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |