FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
PEBA ANCHOR (MULTIPLE SIZES)
K Number: K951451
·
Decision Oct 31, 1995
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
11
Review Days
216
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
- PEBA ANCHOR (MULTIPLE SIZES)
- K Number
- K951451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Orthopaedic Biosystems, Ltd.
- Date Received
- March 29, 1995
- Decision Date
- October 31, 1995
- 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 Orthopaedic Biosystems, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K000797 | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 | Apr 3, 2000 | Substantially Equivalent |
| K982996 | POLYMER OBL SB ANCHOR / SUTURE COMBINATION | Mar 4, 1999 | Substantially Equivalent |
| K983169 | POLYMER THREADED ANCHOR | Dec 16, 1998 | Substantially Equivalent |
| K982963 | POLYMER THREADED ANCHOR / SUTURE COMBINATION | Nov 20, 1998 | Substantially Equivalent |
| K972326 | PEBA ANCHOR/SUTURE COMBINATION | Feb 6, 1998 | Substantially Equivalent |
| K963420 | CANCELLOUS SCREW WASHER | Nov 15, 1996 | Substantially Equivalent |
| K963432 | GUIDE WIRES FOR CANNULATED SCREWS | Nov 13, 1996 | Substantially Equivalent |
| K963433 | THREADED FIXATION PIN | Nov 6, 1996 | Substantially Equivalent |
| K962779 | COMPRESSION SCREW | Aug 23, 1996 | Substantially Equivalent for Some Indications |
| K942889 | SB ANCHOR | Aug 25, 1995 | Substantially Equivalent |