LACTOSORB TRAUMA PLATING SYSTEM
FDA 510(k) clearance K955729 · decided 1996-02-14
Clearance details
- K-number
- K955729
- Device name
- LACTOSORB TRAUMA PLATING SYSTEM
- Applicant
- Poly-Medics,Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-12-18
- Decision date
- 1996-02-14
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915 recall (Z-1872-2008) | Biomet Microfixation, Inc. | 2008-09-16 |