FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACE/FISHER EXTERNAL FIXATOR
K Number: K842768
·
Decision Sep 21, 1984
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
111
Review Days
67
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
- ACE/FISHER EXTERNAL FIXATOR
- K Number
- K842768
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Buckman Co., Inc.
- Date Received
- July 16, 1984
- Decision Date
- September 21, 1984
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTT), ordered by most recent decision date.
MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
DYNEX® External Fixation Systems
FDA 510(k)
FDA Class 2
·Orthopedic
QuikFix External Fixator: Knee-Spanning Pack
FDA 510(k)
FDA Class 2
·Orthopedic
Excelsior System
FDA 510(k)
FDA Class 2
·Orthopedic
Hoffmann LRF System
FDA 510(k)
FDA Class 2
·Orthopedic
Monkey Rings External Ring Fixation 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 |
| K960451 | WEBB-MORLEY SPINE SYSTEM | Apr 18, 1996 | 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 |