FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
INTEGRA(TM) CUSA NXT(TM) BONE TIPS
K Number: K111741
·
Decision Aug 23, 2011
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
1
Review Days
63
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Basic Information
- Device Name
- INTEGRA(TM) CUSA NXT(TM) BONE TIPS
- K Number
- K111741
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra Burlington Ma, Inc. (Formerly Integra Radi
- Date Received
- June 21, 2011
- Decision Date
- August 23, 2011
- Product Code
- LFL
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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