FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
K Number: K981193
·
Decision Jun 16, 1998
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
564
Applicant Total
34
Review Days
75
Basic Information
- Device Name
- INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
- K Number
- K981193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INNOVASIVE DEVICES, INC.
- Date Received
- April 2, 1998
- Decision Date
- June 16, 1998
- 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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|---|---|---|---|
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