Flexmedics Retract Orth Probe, Pettine Bone Probe
FDA 510(k) K912843 · Flexmedics
510(k) numberK912843
Submission
- Device name
- Flexmedics Retract Orth Probe, Pettine Bone Probe
- Applicant
- Flexmedics
Minneapolis, MN, US - Received
- June 26, 1991
- Decision date
- September 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HXB – Probe
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
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| K890227 | Surgical ProbeHXB · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K873652 | Hook Probe #TM-1376HXB · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873651 | Blunt Measuring Probe W/2MM Gradations #TM-1375HXB · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K863149 | Bowen ProbeHXB · Traditional | Bowen & Company, Inc. | 09/05/1986SE |
| K841971 | 2.5MM & 4MM Probe K841969-LABELINGHXB · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K840558 | Shutt Precision ProbesHXB · Traditional | Concept, Inc. | 04/25/1984SE |
| K810294 | Line CaddyHXB · Traditional | Instranetics, Inc. | 02/26/1981SE |
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|---|---|---|
| K990765 | Flexfinder Guide Wire(Regular Shaft/Stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire…OCY · Special | 03/15/1999SE |
| K964955 | Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands…OCY · Traditional | 02/14/1997SE |
| K952430 | Finesse Guidewire CoronaryDQX · Traditional | 08/18/1995SE |
| K943390 | Flexfinder GuidewireDQX · Traditional | 06/27/1995SE |
| K942074 | Flexfinder GuidewireKNY · Traditional | 06/24/1994SE |
| K934265 | Flexmedics Super-Seven Stranded Nickel-Titanium ArchwireDZC · Traditional | 01/21/1994SE |
| K910674 | Flexmedics Malleable CannulaHRX · Traditional | 04/12/1991SE |
| K895899 | Flexmedics Guidewire .012 OnlyDQX · Traditional | 05/23/1990SE |
| K893626 | Flexmedics GuidewireDQX · Traditional | 09/26/1989SE |
| K885086 | Tin Coated Niti Orthodontic Arch WiresEJF · Traditional | 01/10/1989SE |
Questions and answers
When was Flexmedics Retract Orth Probe, Pettine Bone Probe cleared by the FDA?
Flexmedics Retract Orth Probe, Pettine Bone Probe (K912843) received a 510(k) decision of Substantially Equivalent on September 24, 1991, 90 days after the submission was received.
What is the product code of K912843?
The FDA product code is HXB – Probe, a Class I (low risk) device regulated under 21 CFR 888.4540.