Sgarlato Lesser Toe Implant
FDA 510(k) K884739 · Sgarlato Laboratories, Inc.
510(k) numberK884739
Submission
- Device name
- Sgarlato Lesser Toe Implant
- Applicant
- Sgarlato Laboratories, Inc.
San Jose, CA, US - Received
- November 14, 1988
- Decision date
- May 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWH – Prosthesis, Toe, Constrained, Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3720
- Specialty
- Orthopedic
- Implant
- Yes
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| K191966 | NewPrim SystemKWH · Traditional | Brm Extremities | 02/13/2020SE |
| K190136 | Fusion Silastic SystemKWH · Traditional | Fusion Orthopedics, LLC | 10/21/2019SE |
| K173491 | RTS Lesser MTP Implant SystemKWH · Traditional | In2bones USA, LLC | 02/23/2018SE |
| K153609 | RTS Flexible 1 MPJ Implant w/GrommetsKWH · Traditional | In2bones USA, LLC | 09/08/2016SE |
| K102601 | Orthoflex RodKWH · Traditional | Ortho-Pro, LLC | 01/14/2011SE |
| K023531 | Lesser Metatarsal Phalangeal Joint ImplantKWH · Traditional | Nexa Orthopedics, Inc. | 01/17/2003SE |
| K022887 | Interphalangeal Flexible Stabilizing Rod SystemKWH · Traditional | Osteomed Corp. | 11/26/2002SE |
| K022886 | Metatarsophalangeal Flexible Stabilizing Rod SystemKWH · Traditional | Osteomed Corp. | 11/25/2002SE |
| K023562 | Modification to Classic Great Toe ImplantKWH · Special | Nexa Orthopedics, Inc. | 11/13/2002SE |
| K023086 | Classic Great Toe ImplantKWH · Special | Nexa Orthopedics, Inc. | 10/04/2002SE |
More from Nexa Orthopedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043204 | Sgarlato Labs Painfree Pump and Pain Control Infusion PumpFRN · Traditional | 03/30/2005SE |
| K990101 | Pain Control Infusion PumpFRN · Traditional | 03/19/1999SE |
| K982931 | Threaded Fixation PinJDW · Traditional | 10/21/1998SE |
| K926262 | First MPJ Continuous Passive Motion DeviceBXB · Traditional | 01/26/1994SE |
| K926237 | O'Brien GoniometerKQW · Traditional | 08/02/1993SE |
| K922292 | Lundeen Subtalar Peg ImplantMJW · Traditional | 10/23/1992SE |
| K905795 | Sgarlato Flexible Hinge Toe ImplantKWH · Traditional | 05/29/1991SE |
Questions and answers
When was Sgarlato Lesser Toe Implant cleared by the FDA?
Sgarlato Lesser Toe Implant (K884739) received a 510(k) decision of Substantially Equivalent on May 18, 1989, 185 days after the submission was received.
What is the product code of K884739?
The FDA product code is KWH – Prosthesis, Toe, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3720.