FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
K Number: K001044
·
Decision Nov 3, 2000
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
2
Review Days
217
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
- ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
- K Number
- K001044
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Acme Spine, LLC
- Date Received
- March 31, 2000
- Decision Date
- November 3, 2000
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNH), ordered by most recent decision date.
Reliance Spinal Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
CastleLoc Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
FixxSure® X-Link
FDA 510(k)
FDA Class 2
·Orthopedic
Spinal fixation system
FDA 510(k)
FDA Class 2
·Orthopedic
ANAX 5.5 Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
HC Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Acme Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K071824 | ACME TALON PEDICLE SCREW | Sep 4, 2007 | Substantially Equivalent |