INSERTEO, META.-PHAL.&THUMB CARPO-META
FDA 510(k) clearance K771072 · decided 1977-06-27
Clearance details
- K-number
- K771072
- Device name
- INSERTEO, META.-PHAL.&THUMB CARPO-META
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-14
- Decision date
- 1977-06-27
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- HXO
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Depuy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ACETABULAR CUP PUSHER/IMPACTOR (K885305) | Cobot Medical Corp. | 1989-02-08 |
| ACETABULAR CEMENT COMPRESSOR (K803165) | Zimmer, Inc. | 1980-12-31 |
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 |