Chrysalis Intelligence · Product Codes · HBE

HBE · Unclassified

17 clearances · 11 unique sponsors

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Device class

—

Regulation —

Total clearances

17

2021-04-11 → 2026-03-26

Last 12 months

4

Unique sponsors

11

Classification details

Medical specialty

—

Review panel

—

Regulation number

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Implant

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Life-sustain / support

—

GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Surgify Medical OY	4	1	2026-03-26
Nakanishi, Inc.	2	1	2025-09-19
Hubly, Inc.	2	1	2025-11-06
Biomet Microfixation	2	0	2022-11-15
Aesculap, Inc.	1	0	2021-08-24
Stryker Instruments	1	0	2025-03-11
Adeor Medical AG	1	0	2021-04-11
Phasor Health, LLC	1	1	2025-10-31
Medtronic Powered Surgical Solutions	1	0	2021-11-23
Biomet Micofixation	1	0	2022-08-23
Stryker Corporation	1	0	2021-06-30

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
20999	CPT	—	Low	Simple powered burr/drill accessories bundled into procedure codes

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-26	K253627	Surgify Medical OY	Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
2025-11-06	K250815	Hubly, Inc.	Hubly Drill (H100)
2025-10-31	K252060	Phasor Health, LLC	GREEN
2025-09-19	K252662	Nakanishi, Inc.	UniBur
2025-06-04	K251433	Surgify Medical OY	Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)
2025-03-13	K250380	Surgify Medical OY	Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
2025-03-11	K250374	Stryker Instruments	iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R
2023-11-29	K232684	Surgify Medical OY	Surgify Halo
2023-05-04	K230619	Hubly, Inc.	Hubly Electric Drill (H100)
2022-11-15	K223199	Biomet Microfixation	2.1 x 255mm Drill, 22mm Stop
2022-08-23	K213072	Biomet Micofixation	2.1 x 255mm Drill, 22mm Stop
2021-12-23	K213208	Biomet Microfixation	Twist Drills
2021-11-23	K213454	Medtronic Powered Surgical Solutions	Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
2021-10-22	K202120	Nakanishi, Inc.	P300 Attachment
2021-08-24	K203739	Aesculap, Inc.	ELAN 4 Electro Motor System
2021-06-30	K210377	Stryker Corporation	Stryker iBur hubs and cutting accessories
2021-04-11	K191479	Adeor Medical AG	Velocity Alpha Highspeed Surgical Drill System