FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
FDA 510(k) clearance K892059 · decided 1989-07-19
Clearance details
- K-number
- K892059
- Device name
- FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
- Applicant
- Protek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-29
- Decision date
- 1989-07-19
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- LZY
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Indianapolis, 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 |
|---|---|---|
| TANDEM Hip System (K231448) | Smith & Nephew, Inc. | 2023-07-19 |
| ENDO HEAD (K111145) | Medacta International | 2011-08-16 |
| PRE-POWDERED NITRILE EXAMINATION GLOVES (K974442) | P.T. Latexindo Tobaperkasa | 1998-01-05 |
| BHR BIPOLAR FEMORAL HEAD COMPONENT (K915528) | Implantology Corp. | 1993-06-29 |
| IONGUARD TITANIUM MODULAR HEADS (K915548) | Biomet, Inc. | 1992-03-10 |
| MODULAR CATHCART FRACTURE SYSTEM (K903084) | Depuy, Inc. | 1990-10-03 |
| UNI-POLAR HEAD (K896580) | Richards Medical Co., Inc. | 1990-02-15 |
Recalls involving this device
No recalls on record reference this clearance.