HXPClass I
Instrument, Bending Or Contouring
21 CFR 888.4540 / Orthopedic
HXP is the FDA product code for Instrument, Bending Or Contouring, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- HXP
- Device name
- Instrument, Bending Or Contouring
- Regulation
- 21 CFR 888.4540
- Device class
- Class I
- Review panel
- Orthopedic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 1
Clearances, product code HXP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 4 |
| 1987 | 1 |
Applicants with the most clearances
Product code HXP| Applicant | Clearances |
|---|---|
| Stainless Mfg., Inc. | 4 |
| Ace Medical | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 3D MEDICAL MANUFACTURING, Inc. (dba Tecomet)
- AAP Implantate AG
- Addn Solutions GmbH & Co. KG
- Aesculap Inc
- Alphatec Spine, Inc.
- Ambler Surgical, LLC
- Anmuth Medical International LLC
- ARCH Medical Solutions - Elmhurst
- ARCH Medical Solutions - Warsaw
- Aristotech Industries GmbH
- Artfx Medical LLC
- ArthroCare Corporation
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
