SYNTHES (USA) DHS HELIX SYSTEM
FDA 510(k) clearance K981757 · decided 1998-07-17
Clearance details
- K-number
- K981757
- Device name
- SYNTHES (USA) DHS HELIX SYSTEM
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1998-05-19
- Decision date
- 1998-07-17
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- JDO
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Paoli, PA, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |