MITER ENDOSTEAL BLADE IMPLANT
FDA 510(k) clearance K791204 · decided 1979-09-28
Clearance details
- K-number
- K791204
- Device name
- MITER ENDOSTEAL BLADE IMPLANT
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-06-28
- Decision date
- 1979-09-28
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- NRQ
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| PiezoImplant System (K211872) | Rex Implants, Inc. | 2022-10-12 |
| VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS (K981954) | Healthline Implants, Inc. | 1999-01-25 |
| GENERATION 5 LINKOW BLADE IMPLANTS (K822969) | Leonard P. Linkow, D.D.L. | 1982-11-04 |
| ORATRONICS ENDOSSEOUS FRAME ASSEMBLY (K791366) | Oratronics, Inc. | 1979-10-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |