Benderev Drill Guide
FDA 510(k) K923776 · Neimark Labs, Inc.
510(k) numberK923776
Submission
- Device name
- Benderev Drill Guide
- Applicant
- Neimark Labs, Inc.
Mission Viejo, CA, US - Received
- July 28, 1992
- Decision date
- November 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HXY – Brace, Drill
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K892904 | Mitek Drill GuideHXY · Traditional | Mitek Surgical Products, Inc. | 09/28/1989SE |
| K880264 | Bone Suture Fixation DeviceHXY · Traditional | Orthopedic Systems, Inc. | 03/23/1988SN |
| K880381 | Telos Distal Targeting DeviceHXY · Traditional | Austin Assoc. | 03/15/1988SE |
| K880046 | Hasting Finger Fixator InstrumentsHXY · Traditional | Buckman Co., Inc. | 02/16/1988SE |
| K831043 | Andrews Remote Chuck DrillHXY · Traditional | Orthopedic Systems, Inc. | 04/28/1983SE |
| K770204 | Cement Extractor DrillHXY · Traditional | Depuy, Inc. | 02/08/1977SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933536 | Carter-Thomason Needle-Point Suture PasserGCJ · Traditional | 11/22/1993SE |
Questions and answers
When was Benderev Drill Guide cleared by the FDA?
Benderev Drill Guide (K923776) received a 510(k) decision of Substantially Equivalent on November 6, 1992, 101 days after the submission was received.
What is the product code of K923776?
The FDA product code is HXY – Brace, Drill, a Class I (low risk) device regulated under 21 CFR 888.4540.