Raylor(Tm) Mallet

FDA 510(k) K864422 · Cedar Surgical, Inc.

Substantially Equivalent

510(k) numberK864422

Submission

Device name
Raylor(Tm) Mallet
Applicant
Cedar Surgical, Inc.
Minnetonka, MN, US
Received
November 10, 1986
Decision date
November 24, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HWA – Impactor
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HWA

510(k)DeviceApplicantDecision
K933527Modification of Anterior Segment ElectrodesHWA · Traditional Mira, Inc.01/25/1994SE
K841627MalletHWA · Traditional Plastafil, Inc.08/27/1984SE
K770205Cement ChiselsHWA · Traditional Depuy, Inc.02/08/1977SE

More from Depuy, Inc.

510(k)DeviceDecision
K873692Raylor(Tm) Drill StopHBE · Traditional 12/17/1987SE
K872281Raylor Fusion FunnelHXR · Traditional 11/02/1987SE
K873690Cedar(Tm) Pelvic CushionLWG · Traditional 10/26/1987SE
K873691Cedar(Tm) Retractor RingGZT · Traditional 09/28/1987SE
K864425Raylor(Tm) Dissecting HookGDG · Traditional 12/12/1986SE
K864426Raylor(Tm) Depth GaugeHTJ · Traditional 11/26/1986SE
K864424Raylor(Tm) Protective RetractorGAD · Traditional 11/26/1986SE
K864421Raylor(Tm) Periosteal ElevatorsGEG · Traditional 11/26/1986SE
K864423Raylor(Tm) Osteotomes · Traditional 11/24/1986SE
K863416Raylor Mini-ProbeHAO · Traditional 09/24/1986SE

Questions and answers

When was Raylor(Tm) Mallet cleared by the FDA?

Raylor(Tm) Mallet (K864422) received a 510(k) decision of Substantially Equivalent on November 24, 1986, 14 days after the submission was received.

What is the product code of K864422?

The FDA product code is HWA – Impactor, a Class I (low risk) device regulated under 21 CFR 888.4540.