Telos Distal Targeting Device
FDA 510(k) K880381 · Austin Assoc.
510(k) numberK880381
Submission
- Device name
- Telos Distal Targeting Device
- Applicant
- Austin Assoc.
Fallston,, MD, US - Received
- January 27, 1988
- Decision date
- March 15, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K923776 | Benderev Drill GuideHXY · Traditional | Neimark Labs, Inc. | 11/06/1992SE |
| K892904 | Mitek Drill GuideHXY · Traditional | Mitek Surgical Products, Inc. | 09/28/1989SE |
| K880264 | Bone Suture Fixation DeviceHXY · Traditional | Orthopedic Systems, Inc. | 03/23/1988SN |
| 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 |
Questions and answers
When was Telos Distal Targeting Device cleared by the FDA?
Telos Distal Targeting Device (K880381) received a 510(k) decision of Substantially Equivalent on March 15, 1988, 48 days after the submission was received.
What is the product code of K880381?
The FDA product code is HXY – Brace, Drill, a Class I (low risk) device regulated under 21 CFR 888.4540.