MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
FDA 510(k) clearance K082172 · decided 2008-11-28
Clearance details
- K-number
- K082172
- Device name
- MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
- Applicant
- Mako Surgical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-08-01
- Decision date
- 2008-11-28
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- HSX
- Device class
- 2
- Regulation number
- 888.3520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in recall (Z-1385-2023) | Howmedica Osteonics Corp. | 2023-04-12 |
| stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in recall (Z-1386-2023) | Howmedica Osteonics Corp. | 2023-04-12 |