FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K Number: K003735
·
Decision May 8, 2001
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
45
Review Days
155
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
- BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
- K Number
- K003735
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blackstone Medical, Inc.
- Date Received
- December 4, 2000
- Decision Date
- May 8, 2001
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNI), ordered by most recent decision date.
Mikron Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
LumFix Spinal Fixation Sytem
FDA 510(k)
FDA Class 2
·Orthopedic
Double Medical Universal Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
MySpine Pedicle Screw Placement Guides - LP
FDA 510(k)
FDA Class 2
·Orthopedic
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Premier
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 |