ARICULATED TENSION DEVICE SYNTHES TEN
FDA 510(k) clearance K792253 · decided 1979-12-05
Clearance details
- K-number
- K792253
- Device name
- ARICULATED TENSION DEVICE SYNTHES TEN
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1979-11-07
- Decision date
- 1979-12-05
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- HWN
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| AOT EXTERNAL COMPRESS DEVICE (K854241) | Advanced Ortho-Technology, Inc. | 1986-03-03 |
| RIGID TEACHING ATTACHMENT (K770349) | Richard Wolf Medical Instruments Corp. | 1977-03-07 |
| FLORIO CPC BAND (K760970) | Richard'S Medical Equip., Inc. | 1976-11-23 |
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 |