FDA.reportPublic FDA data

ActivL

Primary DI
03662663084338
Brand
ActivL
Company
Highridge Medical, LLC
Model
FW993R-HM
Catalog number
FW993R-HM
Device description
CHISEL GUIDE F/H8.5MM 11DEG
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJOProsthesis, intervertebral disc
QLQManual instruments designed for use with total disc replacement devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJOProsthesis, Intervertebral DiscUnknown3
QLQManual Instruments Designed For Use With Total Disc Replacement DevicesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663084338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663084338036626630843383662663084338

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Microwave Radiation

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags#

DUNS number
119260394
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662663273350Timberline Lateral Fusion System8734-00308734-00302025-12-18
00887868381034Virage 3.0mm tapered Tap 14mm lengthLV01586LV015862026-04-30
00887868523083The TetherLV01666LV016662026-04-22
008884805002164.75mm Reamer ProbeLV00568LV005682026-04-15
00887868259814Radiolucent Pedicle ProbeLV01446LV014462026-04-07
03662663194457SC-AcuFix Anterior Cervical Plate System457-1457-12026-03-31
03662663194464SC-AcuFix Anterior Cervical Plate System474-1474-12026-03-31
03662663194471SC-AcuFix Anterior Cervical Plate System479-1479-12026-03-31
03662663199155Silhouette Spinal Fixation System7010-0003-007010-0003-002026-03-31
03662663199162Silhouette Spinal Fixation System7010-0011-007010-0011-002026-03-31
03662663199179Silhouette Spinal Fixation System7010-0013-007010-0013-002026-03-31
03662663199186Silhouette Spinal Fixation System7010-0014-007010-0014-002026-03-31
03662663199193Silhouette Spinal Fixation System7010-0015-007010-0015-002026-03-31
03662663199209Silhouette Spinal Fixation System7010-0084-007010-0084-002026-03-31
03662663199216Silhouette Spinal Fixation System7010-0133-007010-0133-002026-03-31
03662663199223Silhouette Spinal Fixation System7010-0152-017010-0152-012026-03-31
03662663130929Zyston Interbody Spacer System136M3306136M33062026-03-17
03662663130936Zyston Interbody Spacer System136M3307136M33072026-03-17
03662663131117Zyston Interbody Spacer System139M2606139M26062026-03-17
03662663136693Polaris 5.5 Spinal Fixation System14-50181014-5018102026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M670107751700Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670107751900Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000101Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021205Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021407Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021609Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000022206Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000022408Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000303Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000707Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000080109Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000008020Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009150Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009160Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009250Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009260Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009350Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009360Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009450Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009460Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009550Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009560Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009650Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009660Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010750Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010760Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010850Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010860Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010950Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010960Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17