INSERTER, PLUG, BONE, LIDGE
FDA 510(k) clearance K780283 · decided 1978-03-17
Clearance details
- K-number
- K780283
- Device name
- INSERTER, PLUG, BONE, LIDGE
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-21
- Decision date
- 1978-03-17
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- LGF
- Device class
- 1
- Regulation number
- 888.5940
- 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 |
|---|---|---|
| SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (K043526) | Noble Fiber Technologies, Inc. | 2005-03-10 |
| CLINITEX CAST PADDING (K973420) | Clinitex Medical Corp. | 1997-12-09 |
| CLINITEX STOCKINETTE (K973417) | Clinitex Medical Corp. | 1997-12-09 |
| PROTEC COTTON PADDING BANDAGE (K955320) | Derivadas Degasa S.A. DE C.V. | 1996-01-26 |
| QUICK-CAST IMMOBILIZER (K932507) | Landec Corp. | 1994-02-23 |
| CARAPACE STERILE CAST PADDING (K931672) | Carapace, Inc. | 1993-12-15 |
| ARTIFLEX(TM) (K910274) | Beiersdorf, Inc. | 1991-03-05 |
| COOL CAST(R) (K903946) | Hawthorne Products, Inc. | 1990-12-31 |
| CARAGLAS XTRA SYNTHETIC CASTING TAPE (K896634) | Buckman Co., Inc. | 1990-06-14 |
| SYNTHETIC CAST TAPE (K883294) | Carapace, Inc. | 1988-08-30 |
| COLORED CASTING TAPE CARAGLAS(TM GREEN (K874880) | Synthetic Mfg., Inc. | 1987-12-30 |
| PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 (K873722) | Martin Medical | 1987-10-02 |
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 |