BUECHEL-PAPPAS MODULAR SALVAGE STEM
FDA 510(k) clearance K982418 · decided 1999-04-29
Clearance details
- K-number
- K982418
- Device name
- BUECHEL-PAPPAS MODULAR SALVAGE STEM
- Applicant
- Endotec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-13
- Decision date
- 1999-04-29
- Days to decision
- 290 days
- Clearance type
- Abbreviated
- Product code
- MJT
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- South Orange, NJ, 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 |
|---|---|---|
| OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM (K990712) | Howmedica Osteonics Corp. | 1999-07-20 |
| BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 (K960363) | Biomet, Inc. | 1997-02-18 |
Recalls involving this device
No recalls on record reference this clearance.