FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
LACTOSORB TRAUMA PLATING SYSTEM
K Number: K955729
·
Decision Feb 14, 1996
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
5
Review Days
58
Basic Information
- Device Name
- LACTOSORB TRAUMA PLATING SYSTEM
- K Number
- K955729
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- POLY-MEDICS,INC.
- Date Received
- December 18, 1995
- Decision Date
- February 14, 1996
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by POLY-MEDICS,INC.
| K Number | Device Name | ||
|---|---|---|---|
| K960988 | LACTOSORB TRAUMA PLATING SYSTEM | Apr 10, 1996 | Substantially Equivalent for Some Indications |
| K954443 | LACTOSORB SUTURE ANCHOR | Jan 31, 1996 | Substantially Equivalent for Some Indications |
| K951658 | LACTOSORB POP RIVET | Jul 25, 1995 | Substantially Equivalent for Some Indications |
| K934861 | HARD TISSUE REPLACEMENT (HTR) GRANULAR | Nov 4, 1994 | Substantially Equivalent |