FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
WEBB-MORLEY SPINE SYSTEM
K Number: K960451
·
Decision Apr 18, 1996
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
111
Review Days
79
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
- WEBB-MORLEY SPINE SYSTEM
- K Number
- K960451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Buckman Co., Inc.
- Date Received
- January 30, 1996
- Decision Date
- April 18, 1996
- 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 Buckman Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961320 | CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM | Jun 25, 1998 | Substantially Equivalent |
| K974641 | FUTURELASE 3000/3002 ERBIUM LASER SYSTEM | Jun 8, 1998 | Substantially Equivalent |
| K964252 | ORTHOCHUCK | May 27, 1997 | Substantially Equivalent |
| K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM | Jan 16, 1997 | Substantially Equivalent for Some Indications |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Jan 25, 1996 | Substantially Equivalent |
| K945756 | IMAGN(TM) 2000 SYSTEM | Dec 19, 1995 | Substantially Equivalent |
| K940003 | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT | Oct 19, 1995 | Substantially Equivalent |
| K951117 | LIHTAN 532 LASER | Oct 18, 1995 | Substantially Equivalent |
| K942751 | VANGUARD SERIES GAS REGULATORS | Feb 9, 1995 | Substantially Equivalent |
| K934429 | ANTERIOR SPINE SYSTEM | Oct 20, 1994 | Substantially Equivalent |