The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics Power Broach Impactor.
| Device ID | K895121 |
| 510k Number | K895121 |
| Device Name: | INTERMEDICS POWER BROACH IMPACTOR |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Thomas Craig |
| Correspondent | Thomas Craig INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-15 |
| Decision Date | 1989-09-11 |