Smiljanic Bone Repositioning Forceps
FDA 510(k) K871535 · Link America, Inc.
510(k) numberK871535
Submission
- Device name
- Smiljanic Bone Repositioning Forceps
- Applicant
- Link America, Inc.
East Hanavor, NJ, US - Received
- April 20, 1987
- Decision date
- May 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTD – Forceps
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051281 | The Needle CatcherHTD · Traditional | E.D.Medical , Ltd. | 09/08/2005SE |
| K974595 | Cushing Bayonet, Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974594 | Semkin Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974593 | Semkin Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K913964 | Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional | Marlo Surgical Technology | 10/23/1991SE |
| K911180 | Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K895212 | Tik ExtraktorHTD · Traditional | Instruments of Sweden, Inc. | 09/27/1989SE |
| K890373 | Hemorrhoidal ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890369 | Gall Stone ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890263 | Cilia ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
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| K931571 | Link Ceramic Heads 12/14 X 32MMLZO · Traditional | 04/19/1994SN |
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| K920756 | Feldmuhle Ceramic HeadLZO · Traditional | 05/18/1992SE |
| K914804 | Radius Osteotomy PlatesHRS · Traditional | 04/29/1992SN |
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Questions and answers
When was Smiljanic Bone Repositioning Forceps cleared by the FDA?
Smiljanic Bone Repositioning Forceps (K871535) received a 510(k) decision of Substantially Equivalent on May 14, 1987, 24 days after the submission was received.
What is the product code of K871535?
The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.