Orthopaedic and Spinal Ring Currettes

FDA 510(k) K882072 · Karlin Technology, Inc.

Substantially Equivalent

510(k) numberK882072

Submission

Device name
Orthopaedic and Spinal Ring Currettes
Applicant
Karlin Technology, Inc.
Marina Del Rey, CA, US
Received
May 17, 1988
Decision date
June 17, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JXH – Methyl Methacrylate For Aneurysmorrhaphy
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5030
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code JXH

510(k)DeviceApplicantDecision
K071776Aneuroplastic, Model 43-1290JXH · Special Codman & Shurtleff, Inc.07/26/2007SE
K873688Aneuroplastic, Acrylic Aneuryomorrhaply MaterialJXH · Traditional Dentsply Intl.10/26/1987SE

More from Dentsply Intl.

510(k)DeviceDecision
K903969Suction Retractor(Tower Attach.)For Crank Fram RetGAD · Traditional 09/05/1990SE
K893203Bone ScrewJDR · Traditional 04/04/1990SE
K893201Bone PlateHRS · Traditional 04/04/1990SE
K882525Spinal MicroknifeHTS · Traditional 09/22/1988SE
K882519X-Ray MarkerJAC · Traditional 08/09/1988SE
K882520Shoulder Bolster, Knee, Ankle & Leg Support PadsLWG · Traditional 07/18/1988SE
K882073Spinal NeedleGDM · Traditional 07/18/1988SE
K882524Universally Adjustable ArmboardBTX · Traditional 07/08/1988SE
K882077Microdiscectomy CurrettesLXH · Traditional 06/17/1988SE
K882069Spinal Distractors, SpannersLXH · Traditional 06/17/1988SE

Questions and answers

When was Orthopaedic and Spinal Ring Currettes cleared by the FDA?

Orthopaedic and Spinal Ring Currettes (K882072) received a 510(k) decision of Substantially Equivalent on June 17, 1988, 31 days after the submission was received.

What is the product code of K882072?

The FDA product code is JXH – Methyl Methacrylate For Aneurysmorrhaphy, a Class II (moderate risk) device regulated under 21 CFR 882.5030.