FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
K Number: K081177
·
Decision Jul 23, 2008
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
45
Review Days
89
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Basic Information
- Device Name
- BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
- K Number
- K081177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blackstone Medical, Inc.
- Date Received
- April 25, 2008
- Decision Date
- July 23, 2008
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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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 |
| 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 |
| K073420 | BLACKSTONE ASCENT MULTIAXIAL SCREWS | Feb 14, 2008 | Substantially Equivalent |