OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
FDA 510(k) clearance K111176 · decided 2011-08-15
Clearance details
- K-number
- K111176
- Device name
- OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
- Applicant
- Osteomed LP
- Decision
- Substantially Equivalent
- Date received
- 2011-04-27
- Decision date
- 2011-08-15
- Days to decision
- 110 days
- Clearance type
- Special
- Product code
- GWO
- Device class
- 2
- Regulation number
- 882.5320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Addison, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile recall (Z-2107-2023) | Osteomed, LLC | 2023-07-07 |
| REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile recall (Z-2108-2023) | Osteomed, LLC | 2023-07-07 |