FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
K Number: K061229
·
Decision Jul 24, 2006
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
655
Applicant Total
45
Review Days
83
Basic Information
- Device Name
- UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
- K Number
- K061229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BLACKSTONE MEDICAL, INC.
- Date Received
- May 2, 2006
- Decision Date
- July 24, 2006
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
Resolve Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Frida Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
X-PAC® N-GAGE Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Skyway Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Elegance® Anterior Cervical plate
FDA 510(k)
FDA Class 2
·Orthopedic
Cervical Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by BLACKSTONE MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K093926 | FIREBIRD SPINAL FIXATION SYSTEM | Jul 28, 2010 | Substantially Equivalent |
| K100614 | HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES | May 4, 2010 | Substantially Equivalent |
| K092624 | FIREBIRD SPINAL FIXATION SYSTEM | Sep 25, 2009 | Substantially Equivalent |
| K082797 | BLACKSTONE PEDICLE SCREW SYSTEM | Oct 17, 2008 | Substantially Equivalent |
| K081684 | BLACKSTONE PEDICLE SCREW SYSTEM | Sep 15, 2008 | Substantially Equivalent |
| K082235 | BLACKSTONE PILLAR XL PEEK SPACERS | Sep 4, 2008 | Substantially Equivalent |
| K081849 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE | Aug 28, 2008 | Substantially Equivalent |
| K081177 | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM | Jul 23, 2008 | Substantially Equivalent |
| K080407 | BLACKSTONE SFS PARALLEL ROD CONNECTORS | Mar 13, 2008 | Substantially Equivalent |
| K080394 | BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM | Mar 13, 2008 | Substantially Equivalent |