ORTHOBLEND POWERED BONE MILL
FDA 510(k) clearance K860356 · decided 1986-07-08
Clearance details
- K-number
- K860356
- Device name
- ORTHOBLEND POWERED BONE MILL
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-30
- Decision date
- 1986-07-08
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- LYS
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TRACER BONE MILL (K883183) | De Medica Mfg., Inc. | 1988-10-12 |
| OSTEOMILL BONE GRINDER (K861164) | Biodynamic Technologies, Inc. | 1986-05-02 |
| AESCULAP BONE MILL (K860016) | Aesculap Instruments Corp. | 1986-03-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |