SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR
FDA 510(k) clearance K870844 · decided 1987-03-13
Clearance details
- K-number
- K870844
- Device name
- SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR
- Applicant
- Warsaw Orthopedic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-03
- Decision date
- 1987-03-13
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- HWB
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, 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 |
|---|---|---|
| MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 (K873710) | Arthropedics, Inc. | 1987-11-02 |
| FERRAY EXTRACTOR (K870083) | Terray Manufacturing, Inc. | 1987-02-26 |
| THE EXTRACTOR I TM (K801327) | The Anspach Effort, Inc. | 1980-06-09 |
| HIP PLATE REMOVAL INSTRUMENT (K780300) | Richard'S Medical Equip., Inc. | 1978-02-28 |
Recalls involving this device
No recalls on record reference this clearance.