RD 140 SURGICAL BENDER
FDA 510(k) clearance K870084 · decided 1987-01-28
Clearance details
- K-number
- K870084
- Device name
- RD 140 SURGICAL BENDER
- Applicant
- Terray Manufacturing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-01-08
- Decision date
- 1987-01-28
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- HXW
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ontario K7s 1l8, CA
- 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 |
|---|---|---|
| ACROMED BONE PLATE BENDER (K872949) | Buckman Co., Inc. | 1987-10-15 |
| DRIVER-BENDER-EXTRACTOR, BONE PIN (K870668) | Military Engineering, Inc. | 1987-03-09 |
Recalls involving this device
No recalls on record reference this clearance.