FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTAEON PROBE
K Number: K013429
·
Decision Jan 11, 2002
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
9
Review Days
87
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Basic Information
- Device Name
- ACTAEON PROBE
- K Number
- K013429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteobiologics, Inc.
- Date Received
- October 16, 2001
- Decision Date
- January 11, 2002
- Product Code
- NGR
- 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 |
|---|---|---|---|
| NGR | Tester, Stiffness, Cartilage, Arthroscopic | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NGR), ordered by most recent decision date.
View allOther Clearances by Osteobiologics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051656 | OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM | Oct 25, 2005 | Substantially Equivalent |
| K041382 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | Jun 17, 2005 | Unknown |
| K043172 | TRUGRAFT BGS SYRINGE, MODEL 600-041 | Jan 7, 2005 | Substantially Equivalent |
| K040047 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | Dec 17, 2004 | Substantially Equivalent |
| K033707 | POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX | Aug 16, 2004 | Substantially Equivalent |
| K032673 | IMMIX PLASTIFILM | Oct 2, 2003 | Substantially Equivalent |
| K030288 | POLYGRAFT BONE GRAFT SUBSTITUTE | Jul 17, 2003 | Substantially Equivalent |
| K024199 | IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP | Mar 14, 2003 | Substantially Equivalent |