ORTHOPEDIC SOFT GOODS
FDA 510(k) clearance K771109 · decided 1977-06-27
Clearance details
- K-number
- K771109
- Device name
- ORTHOPEDIC SOFT GOODS
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-20
- Decision date
- 1977-06-27
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- HSS
- Device class
- 1
- Regulation number
- 888.5890
- 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 |
|---|---|---|
| MEDISHIELD CERVICAL COLLAR (K770910) | Fraser Sweatman, Inc. | 1977-05-25 |
| SPLIT CERVICAL COLLAR/HEAD HALTER (K760869) | Orthopedic Equipment Co., Inc. | 1976-11-01 |
Recalls involving this device
No recalls on record reference this clearance.