Femoral Cement Removal Instrument
FDA 510(k) K840735 · Amtech Scientific, Inc.
510(k) numberK840735
Submission
- Device name
- Femoral Cement Removal Instrument
- Applicant
- Amtech Scientific, Inc.
Mchenry, IL, US - Received
- February 21, 1984
- Decision date
- May 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWX – Tap, Bone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HWX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873067 | Acromed Bone Screw Tap SleevesHWX · Traditional | Buckman Co., Inc. | 09/02/1987SE |
Questions and answers
When was Femoral Cement Removal Instrument cleared by the FDA?
Femoral Cement Removal Instrument (K840735) received a 510(k) decision of Substantially Equivalent on May 14, 1984, 83 days after the submission was received.
What is the product code of K840735?
The FDA product code is HWX – Tap, Bone, a Class I (low risk) device regulated under 21 CFR 888.4540.