FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRIME FEMORAL CEMENT PLUG
K Number: K955751
·
Decision Jan 26, 1996
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
8
Review Days
37
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
- PRIME FEMORAL CEMENT PLUG
- K Number
- K955751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthopaedic Innovations, Inc.
- Date Received
- December 20, 1995
- Decision Date
- January 26, 1996
- Product Code
- LZN
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LZN | Cement Obturator | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZN), ordered by most recent decision date.
Artisan Bone Plug, Universal Cement Restrictor
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TORNIER CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CEMSTOP CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOBUCK CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNPLUG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Orthopaedic Innovations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020145 | ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM | Apr 15, 2002 | Substantially Equivalent |
| K983881 | COBRA EXTERNAL FIXATOR | Dec 4, 1998 | Substantially Equivalent |
| K962646 | PRIME MODULAR ENDO HEAD | Sep 23, 1996 | Substantially Equivalent |
| K960014 | PRACTIFIX EXTERNAL FIXATION SYSTEM | Mar 18, 1996 | Substantially Equivalent |
| K955620 | PRIME CEMENTED CALCAR FEMORAL STEMS | Feb 20, 1996 | Substantially Equivalent |
| K953033 | PRIME CEMENTED SMALL FEMORAL STEM | Sep 13, 1995 | Substantially Equivalent |
| K940328 | PRIME CEMENTED HIP SYSTEM | Apr 7, 1995 | Substantially Equivalent for Some Indications |