FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
P.F.C. CEMENT PRESSURIZING SYSTEM
K Number: K943906
·
Decision Dec 21, 1994
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
10
Applicant Total
206
Review Days
132
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
- P.F.C. CEMENT PRESSURIZING SYSTEM
- K Number
- K943906
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4200
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- August 11, 1994
- Decision Date
- December 21, 1994
- Product Code
- KIH
- 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 |
|---|---|---|---|
| KIH | Dispenser, Cement | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIH), ordered by most recent decision date.
SMARTMIX PRE-FILLED MIXING SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
CMW CEMENT PRESSURISATION SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
ORTHOPEADIC CEMENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
PRESSURIZING/SCAVENGING ACRYLIC CEMENT
FDA 510(k)
FDA Class 1
·Orthopedic
BRIGHAM TIBIAL CEMENT PRESSURIZER
FDA 510(k)
FDA Class 1
·Orthopedic
HOWMEDICA FEMORAL PRESSURING SEAL
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Johnson & Johnson Professionals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992173 | SIPHONGUARD CSF CONTROL DEVICE | Apr 7, 2000 | Substantially Equivalent |
| K991413 | CODMAN ETHISORB DURA PATCH | Mar 13, 2000 | Substantially Equivalent |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | Jul 9, 1999 | Substantially Equivalent |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | Dec 18, 1998 | Substantially Equivalent |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Dec 4, 1998 | Substantially Equivalent |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Nov 6, 1998 | Substantially Equivalent |
| K983014 | SUMMIT ACETABULAR SYSTEM | Oct 27, 1998 | Substantially Equivalent |
| K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | Jul 17, 1998 | Substantially Equivalent |
| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | Jul 1, 1998 | Substantially Equivalent |
| K980801 | J-FX BIPOLAR HEAD | May 29, 1998 | Substantially Equivalent |