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510(k) K951811

OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK by Osteotech, Inc. — Product Code LRP

K951811 is an FDA 510(k) premarket notification submitted by Osteotech, Inc. for the device "OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK". The FDA issued a decision of Substantially Equivalent on May 31, 1995. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Osteotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1995
Date Received
April 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Osteotech, Inc.

  • K082615 — GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT (October 16, 2008)
  • K081227 — PLEXUR M (July 22, 2008)
  • K080511 — PLEXUR-P (April 21, 2008)
  • K073405 — PLEXUR M (March 3, 2008)
  • K061982 — PLEXUR P (February 7, 2007)
  • K051188 — GRAFTON DBM (January 3, 2006)
  • K051781 — GRAFTCAGE TLX (December 16, 2005)
  • K051195 — GRAFTON DBM (December 16, 2005)
  • K043209 — VIAGRAF DBM PASTE (December 5, 2005)
  • K053080 — GRAFTCAGE ACX (December 1, 2005)

Other clearances for product code LRP

  • K963723 — LACERATION TRAY (November 27, 1996)
  • K940239 — EYE TRAY (June 28, 1994)
  • K935621 — CUSTOM ENT PACKS (March 30, 1994)
  • K940646 — ORTHOPEDIC TRAY PRODUCT LINE (March 11, 1994)
  • K940444 — GENERAL SURGERY TRAY (March 7, 1994)
  • K922126 — HOSPITAL KIT ENT 1125 (January 21, 1993)
  • K912105 — EYE TRAY (August 29, 1991)
  • K903962 — INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (July 29, 1991)
  • K903963 — KITS AND TRAYS FOR ONE TIME USE ONLY (July 29, 1991)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)

FDA data resources