Bow & Arrow Drill Guide
FDA 510(k) K882407 · Instrument Makar, Inc.
510(k) numberK882407
Submission
- Device name
- Bow & Arrow Drill Guide
- Applicant
- Instrument Makar, Inc.
Okemos, MI, US - Received
- June 10, 1988
- Decision date
- September 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LXI – Guide, Drill, Ligament
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LXI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930573 | Synvasive Ceramic Sutting BlockLXI · Traditional | Synvasive Technology, Inc. | 04/07/1994SE |
| K910712 | Villan (Video Lift Link Analysis)LXI · Traditional | Physio Systems, Inc. | 05/21/1991SE |
| K892655 | Acl Drill Guide SystemLXI · Traditional | Baxter Healthcare Corp | 09/28/1989SE |
| K890445 | Personal Alert Assist DeviceLXI · Traditional | Silent Call Corp. | 05/19/1989SE |
| K881378 | Pfizer Hospital Products Group Acl Drill GuideLXI · Traditional | Pfizer, Inc. | 06/17/1988SE |
| K880739 | Dyonics Drill Guide/Isometer SystemLXI · Traditional | Dyonics, Inc. | 03/21/1988SE |
| K854254 | Tension-IsometerLXI · Traditional | Medmetric Corp. | 11/15/1985SE |
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Questions and answers
When was Bow & Arrow Drill Guide cleared by the FDA?
Bow & Arrow Drill Guide (K882407) received a 510(k) decision of Substantially Equivalent on September 6, 1988, 88 days after the submission was received.
What is the product code of K882407?
The FDA product code is LXI – Guide, Drill, Ligament, a Class I (low risk) device regulated under 21 CFR 878.4820.