Chrysalis Intelligence · Product Codes · HBL

HBL · Holder, Head, Neurosurgical (Skull Clamp)

Neurology · 6 clearances · 2 unique sponsors

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Device class

Class II

Regulation 882.4460

Total clearances

6

2020-02-21 → 2025-11-06

Last 12 months

1

Unique sponsors

2

Classification details

Medical specialty

Neurology

Review panel

NE

Regulation number

882.4460

Implant

N

Life-sustain / support

N

GMP exempt

N

Third-party review

Y

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Pro Med Instruments GmbH	5	0	2024-07-26
Medical Bees GmbH	1	1	2025-11-06

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	Head holder/skull clamp is equipment component bundled into procedure

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-11-06	K250423	Medical Bees GmbH	mb-FIX Cranial Stabilization Systems
2024-07-26	K241883	Pro Med Instruments GmbH	DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)
2024-04-24	K240319	Pro Med Instruments GmbH	DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
2021-03-29	K203505	Pro Med Instruments GmbH	DORO QR3 Headrest System (Aluminum)
2020-06-02	K193438	Pro Med Instruments GmbH	DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
2020-02-21	K191740	Pro Med Instruments GmbH	DORO LUCENT® iXI and iMRI Headrest System