FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNOVASIVE SUTURE BONE FASTENER WITH SUTURE
K Number: K935321
·
Decision Oct 19, 1994
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
34
Review Days
349
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Basic Information
- Device Name
- INNOVASIVE SUTURE BONE FASTENER WITH SUTURE
- K Number
- K935321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Innovasive Devices, Inc.
- Date Received
- November 4, 1993
- Decision Date
- October 19, 1994
- 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 |
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Other Clearances by Innovasive Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994269 | TITAN RC TACK | Jan 10, 2000 | Substantially Equivalent |
| K993975 | ABSOLUTE ABSORBABLE INTERFERENCE SCREW | Dec 20, 1999 | Substantially Equivalent |
| K992458 | RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 | Oct 14, 1999 | Substantially Equivalent |
| K992377 | RC TACK | Oct 8, 1999 | Substantially Equivalent |
| K990454 | BIO-INTERFERENCE SCREW | Jul 1, 1999 | Substantially Equivalent |
| K984490 | SUTURELESS ANCHOR | Mar 1, 1999 | Substantially Equivalent |
| K983560 | INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER | Jan 28, 1999 | Substantially Equivalent |
| K983056 | INNOVASIVE TIBIAL FASTENER | Oct 13, 1998 | Substantially Equivalent |
| K981340 | INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM | Jun 22, 1998 | Substantially Equivalent |
| K981193 | INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER | Jun 16, 1998 | Substantially Equivalent |