Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
FDA 510(k) clearance K143165 · decided 2015-03-31
Clearance details
- K-number
- K143165
- Device name
- Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-03
- Decision date
- 2015-03-31
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- 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 |
|---|---|---|
| Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 He recall (Z-1680-2016) | Zimmer Manufacturing B.V. | 2016-05-16 |
| Product 32 consists of all product under product code: HWC and same usage: Item no: 471154 recall (Z-1130-2016) | Zimmer Manufacturing B.V. | 2016-03-12 |
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|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
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| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
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