Zimmer Biomet Spine Inc

FDA Filings

This page includes the latest FDA filings for Zimmer Biomet Spine Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012447612
• FEI Number: 3012447612
• Name: Zimmer Biomet Spine Inc.
• Owner & Operator: Zimmer Biomet Spine Inc.
• Contact Address: 10225 Westmoor Dr. ; Westminster CO 80021 US
• Official Correspondent:
  • Mike - Medina
  • x-303-5018548-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10225 Westmoor Dr ; Westminster, CO 80021 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3009174179
• FEI Number: 3009174179
• Name: ZIMMER BIOMET SPINE. INC
• Owner & Operator: ZIMMER, INC.
• Contact Address: 345 E. Main Street --; Warsaw IN 46580 US
• Official Correspondent:
  • Michelle Edwards
  • x-800-6136131-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 5400 Meltech Blvd Ste 119 ; Memphis, TN 38118 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMA P110009S031 Zimmer Biomet Spine, Inc.	Mobi-C® Cervical Disc Prosthesis (two-level use)	2021-11-01
PMA P110002S031 Zimmer Biomet Spine, Inc.	Mobi-C® Cervical Disc Prosthesis (one-level use)	2021-11-01
PMN K212023 Zimmer Biomet Spine, Inc.	Virage Navigation System	2021-08-27
PMA P110009S030 Zimmer Biomet Spine, Inc.	Mobi-C® Cervical Disc Prosthesis Two-Level	2021-05-05
PMA P110002S030 Zimmer Biomet Spine, Inc.	Mobi-C® Cervical Disc Prosthesis One-Level	2021-05-05
PMN K210275 Zimmer Biomet Spine, Inc	Polaris Spinal System	2021-04-02
PMA P110009S029 Zimmer Biomet Spine, Inc.	Mobi-C Cervical Disc Prosthesis Two-level	2021-02-17
PMA P110002S029 Zimmer Biomet Spine, Inc.	Mobi-C Cervical Disc Prosthesis One-level	2021-02-17
PMN K203507 Zimmer Biomet Spine, Inc.	Vitality® Spinal Fixation System	2021-01-28
PMA P110009S026 Zimmer Biomet Spine, Inc.	Mobi-C Cervical Disc Prosthesis Two Level	2020-12-15
PMA P110002S026 Zimmer Biomet Spine, Inc.	Mobi-C Cervical Disc Prosthesis One Level	2020-12-15
PMN K202309 Zimmer Biomet Spine, Inc.	Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System	2020-10-08
PMA P110009S024 Zimmer Biomet Spine, Inc.	Mobi-C Cervical Disc Prosthesis (Two-Level Indication)	2020-04-16
PMA P110002S024 Zimmer Biomet Spine, Inc.	Mobi-C Cervical Disc Prosthesis (One-Level Indication)	2020-04-16
PMA P110009S023 Zimmer Biomet Spine, Inc.	Mobi-C Cervical Disc Prosthesis	2020-02-18
PMA P110002S023 Zimmer Biomet Spine, Inc.	Mobi-C Cervical Disc Prosthesis	2020-02-18
PMN K191722 Zimmer Biomet Spine, Inc.	Vital Navigation System	2019-12-02
PMN K192133 Zimmer Biomet Spine, Inc.	Zimmer Biomet Universal Navigation System	2019-10-29
PMN K190556 Zimmer Biomet Spine, Inc.	Zimmer Biomet Universal Navigation System	2019-10-24
PMN K183550 | NKB Zimmer Biomet Spine Inc.	Vitality? Spinal Fixation System	2019-05-16
PMN K183550 | KWQ Zimmer Biomet Spine Inc.	Vitality? Spinal Fixation System	2019-05-16
PMN K183550 | KWP Zimmer Biomet Spine Inc.	Vitality? Spinal Fixation System	2019-05-16
PMN K183550 Zimmer Biomet Spine, Inc.	Vitality® Spinal Fixation System	2019-04-08
PMN K181096 Zimmer Biomet Spine, Inc.	Avenue P Cage System	2019-01-15
PMN K180227 Zimmer Biomet Spine, Inc.	Polaris Spinal Growth System	2018-03-15
PMN K120203 | MQP Zimmer Biomet Spine Inc.	TM-400	2018-02-14
PMN K120203 | MAX Zimmer Biomet Spine Inc.	TM-400	2018-02-14
PMN K171495 Zimmer Biomet Spine Inc.	Zyston Strut Open Titanium Spacer System	2018-02-12
PMN K172275 Zimmer Biomet Spine, Inc.	Vitality® Spinal Fixation System, Vitality®+ Power Instrument System	2017-09-27
PMN K171907 Zimmer Biomet Spine, Inc.	Vitality® Spinal Fixation System	2017-07-14
PMN K163543 Zimmer Biomet Spine Inc.	Biomet Fusion System	2017-02-28
PMN K990131 | MQV Zimmer Biomet Spine Inc.	ProOsteon 500R	2014-05-09
LRP Zimmer Biomet Spine Inc.	Surgical Tray	2014-05-09
HXD Zimmer Biomet Spine Inc.	Clamp	2014-05-09
FZO Zimmer Biomet Spine Inc.	Chisel	2014-05-09
HTR ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Rasp	2007-01-24
HTR ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Endplate Rasp	2007-01-24
FZX ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Guide Tube	2007-01-24
FZX ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Guide Pin	2007-01-24
FZX ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Drill guide	2007-01-24
HXG ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	WIRE TAMP	2006-05-26
HXG ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	SOFT GRAFT TAMP	2006-05-26
HXC ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Ratcheting Deflection Beam Wrench	2006-05-26
HXC ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Derotator	2006-05-26
HWN ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	COMPRESSOR	2006-05-26
HWM ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Osteotome	2006-05-26
HWM ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	BOX OSTEOTOME	2006-05-26
HWA ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	CERVICAL BONE IMPACTOR	2006-05-26
HWA ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	BAYONET IMPACTOR HANDLE	2006-05-26
HTX ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	STRAIGHT	2006-05-26
HTX ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	RONGUER	2006-05-26
HTJ ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	SCREW DEPTH GAUGE	2006-05-26
HTF ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Curette	2003-07-02
FSM ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Various Trays	1999-05-20
FSM ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Universal Sterilization Case	1999-05-20
FSM ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	RETRACTOR CASE	1999-05-20
HXL ZIMMER BIOMET SPINE. INC [ZIMMER, INC.]	Mallet	1978-01-11

Similar & Related FDA Registered Companies

• Zimmer Biomet Spine, Inc.10225 Westmoor Drivewestminster, CO 80021 PMA NumberP110009 Supplement NumberS034 Date Received11/08/2022 Decision Date11/28/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Zimmer Biomet Spine, Inc.10225 Westmoor Drivewestminster, CO 80021 PMA NumberP110002 Supplement NumberS034 Date Received11/08/2022 Decision Date11/28/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Zimmer Biomet Spine, Inc.10225 Westmoor Drivewestminster, CO 80021 PMA NumberP110009 Supplement NumberS032 Date Received01/21/2022 Decision Date11/09/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No