OSTEOTOMY BONE STAPLE
FDA 510(k) clearance K830255 · decided 1983-03-09
Clearance details
- K-number
- K830255
- Device name
- OSTEOTOMY BONE STAPLE
- Applicant
- Techmedica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-25
- Decision date
- 1983-03-09
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- HXJ
- 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 |
|---|---|---|
| IN-TAC BONE ANCHOR SYSTEM (K964953) | Influence, Inc. | 1997-02-13 |
| UROTAC BONE ANCHOR INSERTER (K962372) | Influence, Inc. | 1996-08-19 |
| ELECTRIC WIRE DRIVER, MODEL 2640E (K930205) | Micro Surgical Instruments Corp. | 1993-08-02 |
| FIXATION STAPLE KIT - DLIDE HAMMER (K834515) | Stryker Corp. | 1984-04-23 |
| STAPLE INSERTER-EXTRACTOR FOR ARTHROS (K830456) | Instrument Makar, Inc. | 1983-03-09 |
Recalls involving this device
No recalls on record reference this clearance.