FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
K Number: K992458
·
Decision Oct 14, 1999
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
34
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
- K Number
- K992458
- 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
- July 23, 1999
- Decision Date
- October 14, 1999
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBI), ordered by most recent decision date.
Dione PEEK Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Y-Knotless Flex Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
Anchor with Fiber Wire and Disposable Inserter
FDA 510(k)
FDA Class 2
·Orthopedic
ArthroTAK Tendon Anchor Kit
FDA 510(k)
FDA Class 2
·Orthopedic
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex FiberTak Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| 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 |
| K980491 | INNOVASIVE LINX TIBIAL LIGAMENT FASTENER | Apr 29, 1998 | Substantially Equivalent |