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510(k) K082310

HOLLYWOOD, PACIFICA, REDONDO, VENTURA by Seaspine, Inc. — Product Code MAX

K082310 is an FDA 510(k) premarket notification submitted by Seaspine, Inc. for the device "HOLLYWOOD, PACIFICA, REDONDO, VENTURA". The FDA issued a decision of Substantially Equivalent on November 10, 2008. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Seaspine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2008
Date Received
August 13, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Seaspine, Inc.

  • K231654 — NorthStar OCT System (August 3, 2023)
  • K150469 — Integra Laminoplasty System (March 23, 2015)
  • K142488 — SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, C (December 18, 2014)
  • K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM (May 1, 2014)
  • K132859 — INTEGRA FACET FIXATION SYSTEM (November 18, 2013)
  • K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEM (September 4, 2013)
  • K130830 — INTEGRA LAMINOPLASTY SYSTEM (May 9, 2013)
  • K122571 — MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM (December 12, 2012)
  • K112206 — CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (January 25, 2012)
  • K111671 — SEASPINE MONOPOLAR PROBE SYSYEM (December 28, 2011)

Other clearances for product code MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources